Efficacy of Passive Joint Mobilization vs Mobilization With Movement on Pain Processing in Patients With Chronic Low Back Pain

Sponsor

Universidad Rey Juan Carlos (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04940715

Collaborator

(none)

Enrollment

Location

Arms

5.9

Anticipated Duration (Months)

9.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Patients with chronic low back pain may have altered pain processing, making them vulnerable to pain or disability. It can be measured with test like pressure pain threshold, temporal summation or conditioned pain modulation. Manual therapy has shown improve this pain processing variables in other conditions (like knee osteoarthritis or lateral elbow pain), although the quality of the evidence is low in terms of temporal summation and controversial in terms of conditioned pain modulation. There are not studies that had investigated the impact of manual therapy techniques on pain processing in patients with chronic low back pain.

Condition or Disease	Intervention/Treatment	Phase
Chronic Low-back Pain	Other: Passive joint mobilization Other: Mobilization with movement	N/A

Detailed Description

Study Aims:

Aim #1: The main objective of this study is to determine the efficacy of two manual therapy approaches (passive joint mobilization and mobilization with movement) on pain (measured with Visual Analogue Scale) and pain processing (measured with pressure pain threshold, temporal summation and conditioned pain modulation) in patients with chronic low back pain and see its results on short, medium and long term.

Aim #2: The secondary objective is to compare the effect of both manual therapy techniques with an inactive control group in terms of pain and pain processing.

Aim #3: Determine the efficacy of manual therapy on intervention groups on psychological outcomes as catastrophizing (Pain Catastrophizing Scale), kinesiophobia (Tampa Scale of Kinesiophobia) and depression (Beck Depressive Inventory) and compare them with control group.

Methodology Research Design: Randomized, longitudinal, experimental, prospective, parallel and double-blind study with patients with chronic low back pain.

Participants: Adults between 18-65 years old residing Comunidad de Madrid, all of whom were recruited personally for the study. All patients will read the information sheet explaining what the study will consist, as well as the informed consent form, which they will sign voluntarily beforehand.

Sample Size: The sample size will be calculated by means of the "Gpower 3.0.18" computer program.

Randomization: Randomization will be done through the GraphPad software (GraphPad Software, Inc CA 92037 USA). Patients who meet the inclusion criteria and have none of the exclusion criteria will be entered into the study and the sample will be randomized to obtain three groups in opaque and sealed envelopes: A (passive joint mobilization), B (mobilization with movement) and C (control group).

Masking: The double-blind criteria are met, in which the subjects participating in the study will not know the group to which they were assigned, as well as the physiotherapist in charge of collecting the outcomes data.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

54 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Parallel assignment. Randomized, longitudinal, experimental, prospective, parallel and double-blind study with chronic low back pain adults.Parallel assignment. Randomized, longitudinal, experimental, prospective, parallel and double-blind study with chronic low back pain adults.

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Efficacy of Passive Joint Mobilization vs Mobilization With Movement on Pain Processing in Patients With Chronic Low Back Pain: a Double-blinded, Randomized Clinical Trial.

Anticipated Study Start Date :

Sep 1, 2021

Anticipated Primary Completion Date :

Mar 1, 2022

Anticipated Study Completion Date :

Mar 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Passive joint mobilization Patients lay down on a prone position, with their hands around the body and neck placed comfortable. The therapist performed a postero-anterior joint mobilization using Maitland's technique, applying pressure to spinous process of targeted vertebra (the one who reproduces patient's symptoms).	Other: Passive joint mobilization Dosage: 5 sets of 2 minutes with 30 seconds of rest were applied, with a strong force (>50% of maximum therapist strength), according to patient's irritability and severity.
Experimental: Mobilization with movement Patients perform their painful movement (flexion, extension…). If pain wasn't reproduced, a combination of movements will be performed (flexion + rotation…). The most painful vertebral level was assessed too with passive accessory vertebral movements. Afterwards, with the patient on a seated position on a stretcher with feet supported and a belt around the waist, the therapist performed a sustained glide on the targeted vertebra (spinous process) with the force and direction that relieved pain to the lowest level.	Other: Mobilization with movement Dosage: 3 sets of 10 repetitions were performed, with 1-2 minutes of rest between sets.
No Intervention: Control group Patients were measured at baseline and then were placed on "wait list" until the end of the study. At this time, they were measured again.

Arm

Intervention/Treatment

Experimental: Passive joint mobilization

Patients lay down on a prone position, with their hands around the body and neck placed comfortable. The therapist performed a postero-anterior joint mobilization using Maitland's technique, applying pressure to spinous process of targeted vertebra (the one who reproduces patient's symptoms).

Other: Passive joint mobilization

Dosage: 5 sets of 2 minutes with 30 seconds of rest were applied, with a strong force (>50% of maximum therapist strength), according to patient's irritability and severity.

Experimental: Mobilization with movement

Patients perform their painful movement (flexion, extension…). If pain wasn't reproduced, a combination of movements will be performed (flexion + rotation…). The most painful vertebral level was assessed too with passive accessory vertebral movements. Afterwards, with the patient on a seated position on a stretcher with feet supported and a belt around the waist, the therapist performed a sustained glide on the targeted vertebra (spinous process) with the force and direction that relieved pain to the lowest level.

Other: Mobilization with movement

Dosage: 3 sets of 10 repetitions were performed, with 1-2 minutes of rest between sets.

No Intervention: Control group

Patients were measured at baseline and then were placed on "wait list" until the end of the study. At this time, they were measured again.

Outcome Measures

Primary Outcome Measures

Pain [Change from baseline, after the first intervention, after the last intervention and at both follow-up (1 month and 3 months) periods.]
Visual Analogue Scale (VAS) was used to measure pain. It consists of a 100mm length line and has written "no pain" and "worst pain imaginable" on its ends and measures pain intensity. The confidence and reliability of this scale has been approved and validated in different studies.
Pressure pain threshold [Time Frame: Change from baseline, after the first intervention, after the last intervention and at both follow-up (1 month and 3 months) periods.]
A digital algometer was used to measure mechanical hyperalgesia. The model was de X® brand, consisting of a 1cm2 cylindrical rubber attached to a pressure gauge, calibrated in kilograms (kg). The scale expressed in kg/cm2 was used. Before the measurement, patients were trained in forearm muscles through a trial session. They were instructed to say STOP when the pressure sensation was painful. For the measurement, patients lay down on prone position on the stretcher and the algometer was placed perpendicular to skin on the measured points, who were marked prior to measurement (2cm lateral to L5 spinous process, C2 spinous process, ipsilateral anterior tibialis and contralateral epicondyle). A rest period of 30 seconds was established between the measurements. For each point, three measurements were done and their mean was calculated and recorded for analysis. The minimum detectable change (CMD) for considering the results as clinically relevant was established at 15% minimum.
Temporal summation [Change from baseline, after the first intervention, after the last intervention and at both follow-up (1 month and 3 months) periods.]
Temporal summation was measured with Von Frey monofilaments. Patients lay down on prone position and measurements were taken 1cm lateral to spinous process of L4. First, a single stimulus was applied and the patient assessed the pain intensity on a 0-10 numeric rating scale. After that, 10 rhythmic stimuli were applied on the same spot (1 stimuli per second) and the patient assessed again the pain intensity. The temporal summation effect was calculated as the difference between the mean rating of the three repetitions of one stimulus and the mean rating of the three repetitions of 10 stimulus.
Conditioned pain modulation [Change from baseline, after the first intervention, after the last intervention and at both follow-up (1 month and 3 months) periods.]
Conditioned pain modulation was measured with tourniquet test. A sphygmomanometer was used to induce ischemic muscle pain as conditioning stimulus (model X®). It was applied around the contralateral upper arm, 3cm proximal to cubital fossa. Now, pressure pain threshold 2cm lateral to L5 spinous process was measured. Afterwards, the cuff was inflated to 260mmHg and maintained until the patient perceived a pain intensity of 6 on a 0-10 numeric rating pain scale. Then, the pressure pain threshold was measured again at the same spot during the conditioning stimulus and then the cuff pressure was released. The conditioned pain modulation value is the result of the subtraction of the value of the PPT during the conditioning stimulus minus the PPT without it.

Secondary Outcome Measures

Pain Catastrophizing [Changes from baseline, after the last intervention and at both follow-up periods (1 month and 3 months).]
Catastrophism was measured with Spanish version of Pain Catastrophizing Scale. It's a 13-item self-report measure of catastrophizing and it's constructs as rumination, magnification and helplessness. It must be answered by numeric values between 0 (not at all) and 4 (all the time), with a maximum score of 52 points. The minimal detectable change was identified at 9.1 points.
Kinesiophobia [Changes from baseline, after the last intervention and at both follow-up periods (1 month and 3 months).]
Fear of movement was measured with Spanish version of Tampa Scale of Kinesiophobia. It's an 11-item self-report questionnaire to assess fear of movement-related pain. It's divided on two subscales, one related to Fear of Activity and the other related to Fear of Harm. The score ranges between 11-44 points, with higher scores associated with greater kinesiophobia. The minimal detectable change score was 5.6.
Depression [Changes from baseline, after the last intervention and at both follow-up periods (1 month and 3 months).]
Depressive symptoms were measured with Spanish version of Beck Depressive Inventory. It's a 21-item self-report questionnaire to identify symptoms associated with depression. Each question has a value between 0-3 points, in terms of intensity. The questionnaire assesses cognitive, affective and neurovegetative depressive symptoms, with total score range from 0 to 63.
Central sensitization [Changes from baseline, after the last intervention and at both follow-up periods (1 month and 3 months).]
Central sensitization was measured with Spanish version of Central Sensitization Inventory. This inventory tries to identify the presence of central sensitization. Part A of the questionnaire assess 25 health-related symptoms that are common to central sensitization, with total score ranging from 0 to 100. Part B (not scored) asks about specific disorders or pathologies associated with central sensitization.
Disability [Changes from baseline, after the last intervention and at both follow-up periods (1 month and 3 months).]
Disability was measured with Spanish version of Oswestry Disability Index. This tool assess pain-related disability in people with low back pain. This index assess 1 item on pain and 9 items on activities of daily living (personal care, lifting, walking…). Scores ranges from 0 (no disability) to 100 (maximum disability).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Non-specific chronic low back pain patients, without lower limb pain
Pain lasting 6 months or more
Pain measure of 2 or more on a 0 to 10 scale
Age between 18-65 years old
Haven't received physical therapy during last month

Exclusion Criteria:

Radiculopathy
Neurological signs, symptoms or deficit
Rheumatic/autoimmune/systemic disease
History of fracture, trauma or previous spinal surgery
Pregnancy
Disc herniation
Neuropathic pain
Active cancer
Spondylolysis/Spondylolisthesis
Cognitive impairment
Long-term opioid intake

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Universidad Rey Juan Carlos	Alcorcón	Madrid	Spain	28922

Sponsors and Collaborators

Universidad Rey Juan Carlos

Investigators

Principal Investigator: Oliver Martínez Pozas, PhD candidate, Universidad Rey Juan Carlos (Madrid)
Study Director: Eleuterio A. Sánchez Romero, PhD, Universidad Europea de Madrid (Madrid)
Study Director: Josué Fernández Carnero, PhD, Universidad Rey Juan Carlos (Madrid)
Study Director: Héctor Beltrán Alacreu, PhD, Universidad de Castilla La-Mancha (Toledo)