Pain Treatment in Oncology Population. PaiNEd Study.

Sponsor

Universidad de Granada (Other)

Overall Status

Recruiting

CT.gov ID

NCT04877860

Collaborator

(none)

Enrollment

Location

Arms

16.9

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The objectives of this study are: 1) To design and implement the PaiNEd system for the evaluation and treatment based on Pain Neuroscience Education (PNE) in cancer survivors with sequelae derived from medical treatments; 2) examine the reliability of the PaiNEd system to treat real patients; 3) Study the effectiveness of the PaiNEd system integrated in a multimodal physical recovery program compared to traditional biomedical information.

This project aims to first carry out the design and implementation of an e-health system for the evaluation and treatment of pain, in which 15 cancer survivors will be studied to verify the reliability of the proposal. Secondly, a randomized controlled experimental study will be carried out in which 84 cancer survivors will be recruited and randomly assigned to three study groups.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer Head and Neck Cancer	Other: Multimodal rehabilitation program + PNE (Therapeutic exercise, manual therapy and PNE) Other: Multimodal rehabilitation program + traditional biomedical information Other: Control group	N/A

Detailed Description

People who have suffered cancer often do not find an adequate therapeutic response for the sequelae derived from its treatments. The objectives of this study are: 1) To design and implement the PaiNEd system for the evaluation and treatment based on Pain Neuroscience Education (PNE) in cancer survivors with sequelae derived from medical treatments; 2) examine the reliability of the PaiNEd system to treat real patients; 3) Study the effectiveness of the PaiNEd system integrated in a multimodal physical recovery program compared to traditional biomedical information. In this regard, there is a shortage of proposals for certain subgroups of patients who demand special attention. This project aims to first carry out the design and implementation of an e-health system for the evaluation and treatment of pain, in which 15 cancer survivors will be studied to verify the reliability of the proposal. Secondly, a randomized controlled experimental study will be carried out in which 84 cancer survivors will be recruited and randomly assigned to the three study groups: a) physical recovery program + access to the PaiNEd system; b) physical recovery program + traditional biomedical recommendations; c) control group. The evaluation will be carried out at baseline (at the beginning of the study), at 8 weeks (time of completion of the intervention) and at 6 months of follow-up of the patients.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

84 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Experimental design with two intervention groups and a control group. Effectiveness study. Intervention group 1: multimodal rehabilitation program + PNE Intervention group 2: multimodal rehabilitation program + traditional biomedical information Control group: Patient waiting list.Experimental design with two intervention groups and a control group. Effectiveness study. Intervention group 1: multimodal rehabilitation program + PNE Intervention group 2: multimodal rehabilitation program + traditional biomedical information Control group: Patient waiting list.

Masking:

Double (Participant, Care Provider)

Masking Description:

Participants who meet the inclusion criteria will be randomized into each of the groups using a random number generation program (EPIDAT 4.2, junta de Galicia). The sequence will be placed in an opaque envelope closed by a member outside the investigation and will be opened once the baseline assessment is completed, so the assessment staff will be masked for the randomization of the participants, thus reducing the risk of bias during the evaluation. The blinding of evaluators will be guaranteed by the fact that some members of the group are specialized in the treatment of cancer patients and others in their evaluation.

Primary Purpose:

Treatment

Official Title:

Effectiveness of an E-Health System Integrated in a Physical Recovery Program for the Treatment of Pain in the Oncological Population. PaiNEd Study.

Actual Study Start Date :

Apr 4, 2022

Anticipated Primary Completion Date :

Sep 1, 2022

Anticipated Study Completion Date :

Sep 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Multimodal rehabilitation program + PNE (Therapeutic exercise, manual therapy and PNE) Physical recovery program (multimodal) with a duration of 8 weeks. Three weekly sessions on alternate days lasting 60 minutes each one. 4 individual manual therapy sessions (1 session every 2 weeks). Access to the PaiNEd system.	Other: Multimodal rehabilitation program + PNE (Therapeutic exercise, manual therapy and PNE) The sessions will consist of therapeutic exercise in groups: a) warm-up (10 minutes aerobic exercise), b) active mobilizations (cervical / shoulder) c) strength exercises of the cervical and shoulder muscles + general conditioning d) active postural control e) stretching and relaxation exercises. 4 sessions of myofascial induction. Finally, patients will have access to the PaiNEd system before the start of the program (to prepare them for treatment sessions) and during the development of the treatment program in which they will introduce their pain levels and their characteristics and also receive a series of educational advice and recommendations for its improvement.
Active Comparator: Multimodal rehabilitation program + traditional biomedical information Physical recovery program (multimodal) with a duration of 8 weeks. Three weekly sessions on alternate days lasting 60 minutes each one. 4 individual manual therapy sessions (1 session every 2 weeks). Dossier with traditional biomedical recommendations on the management of pain and disability.	Other: Multimodal rehabilitation program + traditional biomedical information The sessions will consist of therapeutic exercise in groups: a) warm-up (10 minutes aerobic exercise), b) active mobilizations (cervical / shoulder) c) strength exercises of the cervical and shoulder muscles + general conditioning d) active postural control e) stretching and relaxation exercises. 4 sessions of myofascial induction. Patients will receive a dossier with traditional biomedical recommendations on pain management and disability associated with the side effects of cancer treatment.
Active Comparator: Control group Information dossier with recommendations on pain control and dysfunction improvement.	Other: Control group Waiting list of patients who have agreed to participate in the study. They will receive an information dossier with recommendations on pain control and improvement of dysfunction (similar to what was worked on in the experimental group). These recommendations will be distributed at the beginning of the study (initial assessment) and they will be summoned at 8 weeks for the next collection of variables. All patients will be invited to participate in the experimental phase at the end of the control phase.

Arm

Intervention/Treatment

Experimental: Multimodal rehabilitation program + PNE (Therapeutic exercise, manual therapy and PNE)

Physical recovery program (multimodal) with a duration of 8 weeks. Three weekly sessions on alternate days lasting 60 minutes each one. 4 individual manual therapy sessions (1 session every 2 weeks). Access to the PaiNEd system.

Other: Multimodal rehabilitation program + PNE (Therapeutic exercise, manual therapy and PNE)

The sessions will consist of therapeutic exercise in groups: a) warm-up (10 minutes aerobic exercise), b) active mobilizations (cervical / shoulder) c) strength exercises of the cervical and shoulder muscles + general conditioning d) active postural control e) stretching and relaxation exercises. 4 sessions of myofascial induction. Finally, patients will have access to the PaiNEd system before the start of the program (to prepare them for treatment sessions) and during the development of the treatment program in which they will introduce their pain levels and their characteristics and also receive a series of educational advice and recommendations for its improvement.

Active Comparator: Multimodal rehabilitation program + traditional biomedical information

Other: Multimodal rehabilitation program + traditional biomedical information

The sessions will consist of therapeutic exercise in groups: a) warm-up (10 minutes aerobic exercise), b) active mobilizations (cervical / shoulder) c) strength exercises of the cervical and shoulder muscles + general conditioning d) active postural control e) stretching and relaxation exercises. 4 sessions of myofascial induction. Patients will receive a dossier with traditional biomedical recommendations on pain management and disability associated with the side effects of cancer treatment.

Active Comparator: Control group

Information dossier with recommendations on pain control and dysfunction improvement.

Other: Control group

Waiting list of patients who have agreed to participate in the study. They will receive an information dossier with recommendations on pain control and improvement of dysfunction (similar to what was worked on in the experimental group). These recommendations will be distributed at the beginning of the study (initial assessment) and they will be summoned at 8 weeks for the next collection of variables. All patients will be invited to participate in the experimental phase at the end of the control phase.

Outcome Measures

Primary Outcome Measures

Change from baseline in Pain on the Visual Analogue scale and Brief Pain Inventory at 2 and 12 months. [Baseline, 2 and 12 months.]
The Visual Analogue Scale is used to assess the intensity of spontaneous neck, temporomandibular and shoulder pain. The VAS is a 100 mm line anchored with a '0' at one end representing no pain and '100' at the other end representing the worst pain imaginable.

Secondary Outcome Measures

Changes from baseline in Pain Catastrophizing Scale at 2 and 12 months. [Baseline, 2 and 12 months.]
Used to assess catastrophic thinking related to pain. Pain catastrophizing scale is a 13-item self-reported questionnaire. Patients rate how frequent they experience each of 13 items or types of pain experience. It uses a 5-point Likert scale, from 0 (mild symptoms) to 4 (worst symptoms). The total score is derived from the sum of the individual scores for the 13 items. The higher the total score, the more the patient exhibits pain catastrophizing characteristics.
Changes from baseline in Central Sensitization Inventory (CSI) at 2 and 12 months. [Baseline, 2 and 12 months.]
Used to assess if participants have symptoms that may be related to central sensitisation. The Central Sensitization Inventory (CSI) is composed of two different parts. The first one consists of 25 statements, each answer is scored: 0 Never, 1 Rarely, 2 Sometimes, 3 Often, and 4 Always. So that, at most we will be able to obtain a score of 100 and a minimum of 0. The second part is a survey in which patients explain if they have been diagnosed of specific disorders. Higher CSI scores mean greater symptoms of central sensitization. If patients obtain a score greater than or equal to 40, we will consider that they have sufficient psychometrics to be correlated with central sensitization syndromes
Changes from baseline in Kinesiophobia on the Tampa Scale for Kinesiophobia (TSK-11) at 2 and 12 months. [Baseline, 2 and 12 months.]
Kinesiophobia will be measured by an 11-item version of the Tampa Scale for Kinesiophobia (TSK-11). Each item has 4 response options, "strongly disagree" scores 1 point, and "strongly agree" scores 4 points. The maximum possible score is 44 points and the minimum is 11 points. Greater scores mean strong fear of movement.
Changes from baseline in Active shoulder and cervical spine on goniometry at 2 and 12 months. [Baseline, 2 and 12 months.]
A plastic universal goniometer with two adjustable overlapping arms is used to objectively measure the active range of motion of the shoulder joint. An inclinometer device is used to objectively measure the active range of motion of the cervical joints.
Changes from baseline in Quality of life on The European Organization for Research and Treatment of Cancer Breast Cancer-Specific Quality of Life Questionnaire at 2 and 12 months. [Baseline, 2 and 12 months.]
This questionnaire is a breast cancer module of the The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire that contains 23 items rated on a four-point scale ranging from 1 (not at all) to 4 (very much). The items assess the side effects of therapy, arm symptoms, breast symptoms, body image, and sexual function. Additionally, there are single items assessing sexual enjoyment, anxiety caused by hair loss, and future outlook. The scores range between 0-100 points. For scales evaluating function, a higher score represents a higher level of functioning. For scales evaluating symptoms, a higher score indicates more severe symptoms.
Changes from baseline in Quality of life on The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire module for Head and Neck Cancer Patients at 2 and 12 months. [Baseline, 2 and 12 months.]
This questionnaire is a module of The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire and is developed for use among head and neck patients. It provide more detailed information relevant to evaluating the quality of life in the head and neck cancer population. It contains seven multi-item symptom scales (pain, swallowing, taste/smell, speech, social eating, social contacts, and sexuality) and six single-item symptom items (teeth problems, trismus, dry mouth, sticky saliva, cough, and feeling ill). The patient is asked to rate the presence of a symptom or a limitation of a function on a Likert-like scale from either 1 to 4. Five questions of the questionnaire are answered with a "yes" or "no." Scores are transformed to a 0 to 100 scale with higher scores reflecting better outcomes for the functional domains but poorer outcomes for the symptom domains.
Changes from baseline in Functional capacity on the The Six-Minute Walk Test at 2 and 12 months. [Baseline, 2 and 12 months.]
The Six-Minute Walk Test determines the maximum distance (meters) that a person can walk in 6 minutes. The participants are instructed to set their own pace, to "walk as far as they can in 6 minutes", and to volitionally increase or decrease the speed during the test. Standardized phrases of encouragement are given.
Changes from baseline in Isometric handgrip strength on Hand-held Dynamometry at 2 and 12 months. [Baseline, 2 and 12 months.]
Using manual isometric dynamometry with adjustable grip in a standing position with elbow in complete extension. The test is performed 3 times per hand (alternating both hands), with a 1-minute rest between trials. The average score for each hand is registered.
Changes from baseline in Strength endurance deep cervical musculature on cranio-cervical flexion test at 2 and 12 months. [Baseline, 2 and 12 months.]
This test measures the strength of the deep flexor muscles of the neck. It consists of placing the patient in supine position with the spine fully supported on the stretcher and asking him to first, to do a flexion of the upper cervical spine and to simultaneously flex the lower cervical spine. The time that the patient is able to maintain the position without loosing the initial distance that separated him from the stretcher is counted.
Changes from baseline in Body composition by using electrical bioimpedance analysis at 2 and 12 months. [Baseline, 2 and 12 months.]
The electrical impedance analysis is used for estimating body composition, in particular body fat and muscle mass.
Changes from baseline in Heart rate variability through a holter recorder at 2 and 12 months. [Baseline, 2 and 12 months.]
Heart rate variability is measured with a holter recorder. A high heart rate variability means that the body is responsive to both sets of inputs (parasympathetic and sympathetic). This is a sign that the nervous system is balanced, and that the body is capable of adapting to its environment and performing at its best.
Changes from baseline in stress and inflammatory responses at 2 and 12 months. [Baseline, 2 and 12 months.]
Salivary Cortisol, Interleukin-6 and C-reactive protein biomarkers are analyzed.
Changes from baseline in Fatigue on The Piper Fatigue Scale-Revised at 2 and 12 months [Baseline, 2 and 12 months.]
The Piper Fatigue Scale-Revised incorporates 27 items, 22 of which evaluate the perception of current fatigue using a 0-10 Likert scale. Results can be summarised into four dimensions (subscales) of subjective fatigue: behavioural/severity; affective meaning; sensory; and cognitive/mood. A cancer related fatigue score of 1-3 designates mild fatigue; 4-6 corresponds to moderate fatigue; and 7-10 indicates severe fatigue.
Changes from baseline in Specific assessment of nutritional / oral status on Eating Assessment Tool at 2 and 12 months. [Baseline, 2 and 12 months.]
The Eating Assessment Tool is a 10-item self-administered questionnaire developed to evaluate dysphagia symptoms in persons with a wide variety of causes of dysphagia and in different clinical settings. It consists of 10 questions about the severity of symptoms of oropharyngeal dysphagia and its clinical and social impact, each question scoring from 0 (no problem) to 4 (severe problem).
Changes from baseline in Sleep quality on The Pittsburgh Sleep Quality Index at 2 and 12 months. [Baseline, 2 and 12 months.]
The Pittsburgh Sleep Quality Index is used to measure the quality and patterns of sleep over the last month. The questions are framed in a 4-point Likert scale (0-3) and analyze seven factors including subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medications, and daytime dysfunction. The scores from each component are added to give a sum score, also called a global score (range 0-21), where lower scores denote a healthier sleep quality.
Changes from baseline in Pressure Pain Thresholds (Algometry) at 2 and 12 months. [Baseline, 2 and 12 months.]
Pressure Pain Threshold is the minimal amount of pressure where a sensation of pressure first changes to pain. It will be performed at the points related to the cervical area and the shoulder girdle (joint C5-C6, upper trapezius, levator scapulae, masseter, deltoid, sternoclavicular joint and tibialis anterior) with an algometer. The pressure is applied at a rate of approximately 30 kilopascals / seconds by a 1-cm2 probe. Participants will be instructed to press the switch when the sensation first change from pressure to pain. The mean of 3 trials is calculated and used for the analysis. A 30-second resting period is allowed between each trial.
Changes from baseline in Shoulder functionality (upper limb) on Shoulder Pain Disability Index Questionnaire (SPADI) at 2 and 12 months. [Baseline, 2 and 12 months.]
The shoulder pain and disability index is a 13-item, self-administered questionnaire with two subscales: pain and disability. Subjects report the pain and disability experienced in the previous week. Each item is rated on a 0-10 scale, from no pain/no dysfunction 0 to maximum pain/impossible 10. The scores for pain and disability are calculated from the sum of the corresponding items divided by the maximum score possible and multiplied by 100. To obtain the total score, the mean of the pain and disability scores is calculated.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Subjects over 18 years of age.
Having undergone surgery and finished adjuvant treatment (radiotherapy and / or chemotherapy) six months or two years ago.
Not having active cancer.
Having pain in the regions related to the tumor area (orofacial and / or cranial and / or cervical and / or brachial and / or shoulder), pain ≥ 4 (VAS 0 to 10) for> 4 weeks
Present musculoskeletal or functional alterations in the previous regions.

Exclusion Criteria:

Identification by the research team of physical or mental impossibility to carry out the tests of the study.
Suffering from chronic pain or having suffered a previous trauma to the spine, head, temporomandibular joint or upper extremities.