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Effects of Core Exercise in Low Back Pain

Primary Purpose

Low Back Pain

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Exercise
Manual Therapy
Kinesiotape
Sponsored by
Universitat Jaume I
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring Chronic pain, Muskuloskeletal manipulation, Complementary therapies, Catastrophization, Kinesiophobia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Universitat Jaume I

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Therapeutic exercise Group (ET)

Manual Therapy group (ETmanualtherapy)

Kinesiotape Group (ETkinesiotape)

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Oswestry Disability Index.
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)
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)
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)
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
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
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
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.

Full Information

First Posted
September 8, 2022
Last Updated
January 18, 2023
Sponsor
Universitat Jaume I
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1. Study Identification

Unique Protocol Identification Number
NCT05544890
Brief Title
Effects of Core Exercise in Low Back Pain
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.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
September 20, 2022 (Actual)
Primary Completion Date
December 20, 2022 (Actual)
Study Completion Date
December 23, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universitat Jaume I

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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?
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
Keywords
Chronic pain, Muskuloskeletal manipulation, Complementary therapies, Catastrophization, Kinesiophobia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare 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.
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Therapeutic exercise Group (ET)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Manual Therapy group (ETmanualtherapy)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Kinesiotape Group (ETkinesiotape)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Exercise
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
Manual Therapy
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
Kinesiotape
Intervention Description
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
Primary Outcome Measure Information:
Title
Oswestry Disability Index.
Description
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.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Catastrophism (PCS)
Description
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.
Time Frame
12 weeks
Title
Kinesiophobia (TKS)
Description
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.
Time Frame
12 weeks
Title
Visual analog scale (VAS)
Description
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.
Time Frame
12 weeks
Title
Self-efficacy:questionnaire
Description
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.
Time Frame
12 weeks
Title
Pressure pain threshold
Description
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.
Time Frame
12 weeks
Title
Electromyography
Description
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.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paula Blanco, PDI
Organizational Affiliation
Doctoral School. Catholic University of Valencia San Vicente Mártir
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universitat Jaume I
City
Castellón De La Plana
State/Province
Castellón
ZIP/Postal Code
12071
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
24665116
Citation
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PubMed Identifier
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Effects of Core Exercise in Low Back Pain

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