Effects of Core Exercise in Low Back Pain

Sponsor

Universitat Jaume I (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05544890

Collaborator

(none)

Enrollment

Arms

3.6

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

Non-specific low back pain in one of the main causes of disability for health care worldwide. The effectiveness of therapeutic exercise, of kinesio tape and of manual therapy in the treatment of low back pain is evaluated, but not a comparison of these techniques. Moreover, can these techniques be combined?

Condition or Disease	Intervention/Treatment	Phase
Low Back Pain	Procedure: Exercise Procedure: Manual Therapy Procedure: Kinesiotape	N/A

Detailed Description

Non-specific low back pain is one of the main causes of disability for health care worldwide. Nowadays, the mostly used technique to research low back muscular activity in electromyography.

Among the published studies, the effectiveness of therapeutic exercise, of kinesio tape and of manual therapy in the treatment of low back pain is evaluated, but not a comparison of these techniques.

Therefore, the purpose of this study was to investigate the effects of core stability exercise alone or in combination with manual therapy or kinesiotape on pain, dysfunction, psychosocial factors and pressure pain threshold (PPTs) in patients with low back pain in ODI stage 2. The investigators hypothesized that exercise combined with manual therapy would provide greater changes and benefits than exercise alone.

This study's population will be composed by at least 15 individuals per group, both the male and female, with ages among 20 and 60.

Participants will be randomly and blindly divided in three groups of intervention. The three groups will be: Exercise group or ET (realize therapeutic exercise alone), manual therapy group o ETmanualtherapy (realize manual therapy prior therapeutic exercise), and kinesiotape group or ETkinesiotape (realize therapeutic exercise plus kinesiotape).

Study Design

Study Type:

Interventional

Anticipated Enrollment :

70 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Care Provider)

Masking Description:

The groups will be arranged randomly and the masking technique to be used will be the doble blind procedure. The subjects will be randomly selected through the EPIDAT 4.2 program. The random allocation to each group will be made just by one external researcher, this way, neither the main researcher, nor the participants, will know their allocation. Furthermore, the inspector who will collect the evaluation data won´t know the allocation of each subject.

Primary Purpose:

Treatment

Official Title:

Core Stability (Therapeutic) Exercise Alone or in Combination With Manual Therapy or Kinesio Tape in Patients With Chronic Low Back Pain: Randomized Control Trial.

Anticipated Study Start Date :

Sep 28, 2022

Anticipated Primary Completion Date :

Jan 15, 2023

Anticipated Study Completion Date :

Jan 15, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Therapeutic exercise Group (ET) The ET group is going to follow a program of core stabilization through specific therapeutic exercise. Two weekly sessions will be programmed for 12 weeks, making a total of 24 sessions. Each session will have a duration of 60 minutes. All patients will start learning how to activate the transversus abdominal muscle in the first training session. The exercises will be made in 1 to 3 series of among 8 and 15 repetitions and the isometric contractions for 5 to 10 seconds. The rest between series will be of 30 seconds, and between exercise of 2-3 minutes.	Procedure: Exercise All patients will start learning how to activate the transversus abdominal muscle in the first training session. The exercises will be made in 1 to 3 series of among 8 and 15 repetitions and the isometric contractions for 5 to 10 seconds. The rest between series will be of 30 seconds, and between exercise of 2-3 minutes. Other Names: - Therapeutic exercise
Active Comparator: Manual Therapy group (ETmanualtherapy) Prior the core exercise previously exposed in group ET, group ETmanualtherapy will lay on the stretcher, where the physiotherapist will work on a manual therapy thrust. The participant will receive a high velocity and low range impulse technique in lateral position on both sides.	Procedure: Exercise All patients will start learning how to activate the transversus abdominal muscle in the first training session. The exercises will be made in 1 to 3 series of among 8 and 15 repetitions and the isometric contractions for 5 to 10 seconds. The rest between series will be of 30 seconds, and between exercise of 2-3 minutes. Other Names: - Therapeutic exercise Procedure: Manual Therapy All patients will start learning how to activate the transversus abdominal muscle in the first training session. The exercises will be made in 1 to 3 series of among 8 and 15 repetitions and the isometric contractions for 5 to 10 seconds. The rest between series will be of 30 seconds, and between exercise of 2-3 minutes. Other Names: - Manipulation
Active Comparator: Kinesiotape Group (ETkinesiotape) The ETkinesiotape will go previously through physiotherapy, where a kinesiotape band will be applied (Kinesiotape "Nondolens" 5cmx5cm black color), in Y technique, by applying the kinesiotape base in neutral position of the lumbar spine without any tension on the tape. The participants realize the same exercise program than the other groups plus the kinesiotape applied.	Procedure: Exercise All patients will start learning how to activate the transversus abdominal muscle in the first training session. The exercises will be made in 1 to 3 series of among 8 and 15 repetitions and the isometric contractions for 5 to 10 seconds. The rest between series will be of 30 seconds, and between exercise of 2-3 minutes. Other Names: - Therapeutic exercise Procedure: Kinesiotape All patients will start learning how to activate the transversus abdominal muscle in the first training session. The exercises will be made in 1 to 3 series of among 8 and 15 repetitions and the isometric contractions for 5 to 10 seconds. The rest between series will be of 30 seconds, and between exercise of 2-3 minutes. Other Names: - Kinesiotaping

Arm

Intervention/Treatment

Active Comparator: Therapeutic exercise Group (ET)

The ET group is going to follow a program of core stabilization through specific therapeutic exercise. Two weekly sessions will be programmed for 12 weeks, making a total of 24 sessions. Each session will have a duration of 60 minutes. All patients will start learning how to activate the transversus abdominal muscle in the first training session. The exercises will be made in 1 to 3 series of among 8 and 15 repetitions and the isometric contractions for 5 to 10 seconds. The rest between series will be of 30 seconds, and between exercise of 2-3 minutes.

Procedure: Exercise

All patients will start learning how to activate the transversus abdominal muscle in the first training session. The exercises will be made in 1 to 3 series of among 8 and 15 repetitions and the isometric contractions for 5 to 10 seconds. The rest between series will be of 30 seconds, and between exercise of 2-3 minutes. Other Names: - Therapeutic exercise

Active Comparator: Manual Therapy group (ETmanualtherapy)

Prior the core exercise previously exposed in group ET, group ETmanualtherapy will lay on the stretcher, where the physiotherapist will work on a manual therapy thrust. The participant will receive a high velocity and low range impulse technique in lateral position on both sides.

Procedure: Exercise

Procedure: Manual Therapy

Active Comparator: Kinesiotape Group (ETkinesiotape)

The ETkinesiotape will go previously through physiotherapy, where a kinesiotape band will be applied (Kinesiotape "Nondolens" 5cmx5cm black color), in Y technique, by applying the kinesiotape base in neutral position of the lumbar spine without any tension on the tape. The participants realize the same exercise program than the other groups plus the kinesiotape applied.

Procedure: Exercise

Procedure: Kinesiotape

Outcome Measures

Primary Outcome Measures

Oswestry Disability Index. [12 weeks]
The Oswestry Disability Index (ODI) test will be made to all participants at three months. Divided into 10 sections (each is scored from zero to five, with higher scores meaning higher disability), it is self-administered to assess the limitations of different activities of daily living. That is why, it has been established that all participants in Stage 2 of the test are subsidiaries to make all the treatment modes of the study (manual therapy, kinesiotape and exercise). This way, we are able to rise the homogeneity that imposes a diagnostic label such as the chronic low back pain.

Secondary Outcome Measures

Catastrophism (PCS) [12 weeks]
To quantify the degree of catastrophism in the present study, the validated spanish version will be used as the pain catastrophism scale (PCS). The PCS is a 13-item self-report scale of 13 items, that presents same factor structure composed of the factors of rumination, despair and magnification. For each of these factors, it is given a value of 0 (without agreement) to 4 (always), so that at the end the examiner obtains a score between 0 and 52. Low scores indicate a low level of catastrophism and high values show high levels of catastrophism.
Kinesiophobia (TKS) [12 weeks]
The mostly used questionnaire to evaluate kinesiophobia is the TKS (Tampa Kinesiophobia Scale) questionnaire, which we will use to measure which is the fear to movement of patients of low back pain. This scale includes work related lesions, lesions due to repetitive effort, relapses and the avoidance-fear. The questionnaire is composed of 17 items in which there is a differentiation between the negative and positive elements. This questionnaire will be filled in based on a Likert sale which ranges between 0 and 5, being 0 never and 5 always. The total punctuation ranges between 17 and 68, the higher the rate, the higher the degree of kinesiophobia.
Visual analog scale (VAS) [12 weeks]
The VAS from 0 to 100, the scale considered to be the most representative, with the VAS being the best option due to its easy understanding and handling. This scale constitutes an effective tool to subjectively quantify this range, more discriminating than the scale that establishes its values from 0 to 10. This way, 0 will be considered as non-existent pain reflected by the individual and 10 as the worst pain imaginable by the patient.
Self-efficacy:questionnaire [12 weeks]
To assess self-efficacy, it will be used the Chronic Pain Self-Efficacy Questionnaire, which assesses a person's belief in their ability to perform a specific behavior. It consists of 19 items, a Likert-type scale, and a response range of 0 to 10, where 0 is equivalent to feeling totally incapable, 5 moderately incapable and 10 fully capable. The result determines that the higher the score, the greater the degree of self-efficacy.
Pressure pain threshold [12 weeks]
Pressure pain threshold (PPTs) is considered a useful method to calculate the degree of sensitization of deep tissues. It will be carried out using an algometer, which in this study will consist of a manometer attached to a cylindrical rubber tip. The manometer measures the pressure applied through the rubber and the patient should signal when this pressure starts being painful). Algometry is a widely studied and validated technique to quantify sensitivity in the diagnosis of symptomatic points and myofascial trigger points. The reliability of pressure pain threshold is relatively high, presenting coefficients of 0.9 and 0.95.
Electromyography [12 weeks]
To obtain an objective measure of the muscle activation, surface electromyography will be used to evaluate the main core muscles - basically the rectus abdominis and multifidus. The electromyograph to be used will be the FREEEMG model of the brand BTS Bioengineering. It is a wireless electromyograph with probes attached to the prefilled electrodes, which collect the information. No additional hardware is required, as the same software processes the information taken. The data resolution is 16 bit and the frequency of 1 kHz.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Medical diagnosis of CLBP confirmed by an orthopaedic specialist Classification at Stage 2 by ODI Not receiving pharmacological treatment such as anti-inflammatories or corticosteroids.

Exclusion Criteria:

Previous or scheduled surgeries in the low back and abdominal area
Presence of severe fractures or pathologies.
Diagnosis of radiculopathy or neuropathy (with or without spinal canal stenosis).
Structural deformity in the spinal column.
Neurological or psychiatric disorder.
Presence or suspicion of pregnancy.