Manipulative Therapy Techniques to Treat Chronic Low Back Pain
Primary Purpose
Low Back Pain, Chronic Disease
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Manipulative Therapy Techniques
Functional Technique
Sponsored by
About this trial
This is an interventional treatment trial for Low Back Pain focused on measuring Low back pain., Manipulative therapy techniques., Randomized controlled trial., Chronic pain.
Eligibility Criteria
Inclusion Criteria:
- Low back pain for ≥ 3 months.
- Score ≥4 on the Roland Morris disability questionnaire.
- No undergoing another physical therapy treatment.
- Inability to achieve lumbar muscle flexion-relaxation in trunk flexion
Exclusion Criteria:
- Clinical signs of radiculopathy.
- Presence of lumbar stenosis.
- Fibromyalgia.
- Spondylolisthesis.
- History of spinal surgery.
- Treatment with corticosteroids in the past two weeks.
- Disease of the central or peripheral nervous system.
Sites / Locations
- Adelaida María Castro-Sánchez
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Manipulative Therapy Techniques
Functional Technique
Arm Description
Manipulative Therapy Techniques involve three techniques on lumbar and sacral areas. This protocol will be administered one a week for 3 weeks.
Manipulative Therapy Technique involves one technique on lumbar area. This protocol will be administered one a week for 3 weeks.
Outcomes
Primary Outcome Measures
Roland Morris Disability Questionnaire (RMDQ)
The Roland Morris disability questionnaire is a self-administered disability measurement scored on a 24-point scale from 0 = no disability to 24 = severe disability.
Secondary Outcome Measures
Oswestry Disability Index (ODI)
The Oswestry disability index evaluates daily life activity limitations in 10 dimensions, each scored on a 6-point scale (0-5 points); the total points scored are expressed as a percentage, used to classify individuals as minimally disabled (0-10%), moderately disabled (20-40%), severely disabled (40-60%), crippled (60-80%), or bedbound (80-100%).
Visual Analogue Scale (VAS)
The visual analogue scale for pain intensity ranged from 0 = no pain to 10 = worst imaginable pain.
Tampa Scale for Kinesiophobia (TSK)
The Tampa Scale for Kinesiophobia comprises 17 items on the fear of movement or recurrent lesion, each scored on a 4-point Likert scale from "completely disagree" to "completely agree".
Quality of Life
SF-36 Health Questionnaire scores range from 0 to 100% and indicate the self-perceived health-related quality of life.
Isometric Resistance of Abdominal Muscles
The McQuade test measures the isometric resistance of abdominal muscles in seconds.
Lumbar Mobility in Flexion
Lumbar mobility in flexion was determined by measuring the distance from the tip of the third finger to the floor with a tape measure.
Full Information
NCT ID
NCT01796496
First Posted
February 20, 2013
Last Updated
October 3, 2015
Sponsor
Universidad de Almeria
Collaborators
Universidad de Granada, Universidad Rey Juan Carlos
1. Study Identification
Unique Protocol Identification Number
NCT01796496
Brief Title
Manipulative Therapy Techniques to Treat Chronic Low Back Pain
Official Title
Short-term Effect of Manipulative Therapy Techniques in People With Chronic Low Back Pain: A Randomized Controlled Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
November 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad de Almeria
Collaborators
Universidad de Granada, Universidad Rey Juan Carlos
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to analyze the effectiveness of a three manipulative therapy techniques in People with Chronic Low Back Pain.
Detailed Description
Objective: To analyze the effectiveness of a three manipulative therapy techniques in individuals with chronic non-specific low back pain of mechanical etiology.
Design: Randomized clinical trial. Setting: Almeria, South Spain. Participants: Sixty two with chronic non-specific low back pain will be randomly assigned to an experimental or control group.
Intervention: For 3-week, the experimental group will undergo treatment comprising 3 sessions (1/week) of manipulative therapy techniques in the lumbar and sacral areas, and the control group will receive a functional technique in the lumbar area.
Main Outcome Measures: Oswestry disability index, pain visual analogue scale, Tampa scale for kinesiophobia, Roland-Morris disability questionnaire, McQuade test, quality of life scores and the range of trunk anteflexion motion, which were all assessed before the treatment and immediately after the last treatment session.
The primary outcome measure is the change in the RMDQ score at the end of the 3 weeks study period. A difference of 2.5 point is considered to be the minimum clinically important difference in the RMDQ score. A sample size of 62 patients (31 per group) would enable detection of a 2.5 point difference between groups given 80-90% power, a 5% (two-tailed) significance level, and a conservative standard derivation of 5 points. Key baseline demographic variables and clinical measure scores will be compared between groups by using independent Student t tests for continuous data and chi-square tests for categorical data. Separate 2x2 mixed model ANOVA with repeated measurements for the time factor need to be conducted in order to test between-groups differences in visual analogue scale, McQuade test, range of trunk anteflexion motion, Oswestry disability index, Roland Morris disability questionnaire, Tampa scale for kinesiophobia, and quality of life as the dependent variables, with group (functional technique or three manipulative therapy techniques) as the between subjects variable and time (baseline, post-treatment). A paired t-test will perform to test within-group differences in score changes from pre- to post-treatment. Effect size will test using Cohen's d. p = 0.05 will be considered significant in all tests.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain, Chronic Disease
Keywords
Low back pain., Manipulative therapy techniques., Randomized controlled trial., Chronic pain.
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
62 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Manipulative Therapy Techniques
Arm Type
Experimental
Arm Description
Manipulative Therapy Techniques involve three techniques on lumbar and sacral areas. This protocol will be administered one a week for 3 weeks.
Arm Title
Functional Technique
Arm Type
Active Comparator
Arm Description
Manipulative Therapy Technique involves one technique on lumbar area. This protocol will be administered one a week for 3 weeks.
Intervention Type
Other
Intervention Name(s)
Manipulative Therapy Techniques
Intervention Description
Global Technical bilateral pelvis: The technique involves inserting a small spine rotation and make a slack in three stages.
Indirect technique of lumbar roll in rotation for bilateral L3: to reduce the slack and make the body drop simultaneously, together with a high speed contraction pectoral muscles and triceps, iliac crest leading caudad which produces a rotation of the vertebra underlying joint space opening.
Dog-technic on D12: this technique reduces the slack in the abdomen toward the hand in contact with D12. Next, the therapist conducted a thrust in the direction of the reduction.
Intervention Type
Other
Intervention Name(s)
Functional Technique
Intervention Description
The therapist presses the two anterior superior iliac spines to open the back of the pelvis, this maintained throughout the technique. Then patient is asked to breathe deeply and exhale, sacrum makes a flexion-extension respectively. These movements should be symmetrical and of equal duration in time.
Primary Outcome Measure Information:
Title
Roland Morris Disability Questionnaire (RMDQ)
Description
The Roland Morris disability questionnaire is a self-administered disability measurement scored on a 24-point scale from 0 = no disability to 24 = severe disability.
Time Frame
At baseline, 3 weeks and 7 weeks
Secondary Outcome Measure Information:
Title
Oswestry Disability Index (ODI)
Description
The Oswestry disability index evaluates daily life activity limitations in 10 dimensions, each scored on a 6-point scale (0-5 points); the total points scored are expressed as a percentage, used to classify individuals as minimally disabled (0-10%), moderately disabled (20-40%), severely disabled (40-60%), crippled (60-80%), or bedbound (80-100%).
Time Frame
At baseline, 3 weeks and 7 weeks
Title
Visual Analogue Scale (VAS)
Description
The visual analogue scale for pain intensity ranged from 0 = no pain to 10 = worst imaginable pain.
Time Frame
At baseline, 3 weeks and 7 weeks
Title
Tampa Scale for Kinesiophobia (TSK)
Description
The Tampa Scale for Kinesiophobia comprises 17 items on the fear of movement or recurrent lesion, each scored on a 4-point Likert scale from "completely disagree" to "completely agree".
Time Frame
At baseline, 3 weeks and 7 weeks
Title
Quality of Life
Description
SF-36 Health Questionnaire scores range from 0 to 100% and indicate the self-perceived health-related quality of life.
Time Frame
At baseline, 3 weeks and 7 weeks
Title
Isometric Resistance of Abdominal Muscles
Description
The McQuade test measures the isometric resistance of abdominal muscles in seconds.
Time Frame
At baseline, 3 weeks and 7 weeks
Title
Lumbar Mobility in Flexion
Description
Lumbar mobility in flexion was determined by measuring the distance from the tip of the third finger to the floor with a tape measure.
Time Frame
At baseline, 3 weeks and 7 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Low back pain for ≥ 3 months.
Score ≥4 on the Roland Morris disability questionnaire.
No undergoing another physical therapy treatment.
Inability to achieve lumbar muscle flexion-relaxation in trunk flexion
Exclusion Criteria:
Clinical signs of radiculopathy.
Presence of lumbar stenosis.
Fibromyalgia.
Spondylolisthesis.
History of spinal surgery.
Treatment with corticosteroids in the past two weeks.
Disease of the central or peripheral nervous system.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adelaida M Castro-Sánchez, PhD
Organizational Affiliation
Universidad de Almeria
Official's Role
Study Director
Facility Information:
Facility Name
Adelaida María Castro-Sánchez
City
Almeria
ZIP/Postal Code
04120
Country
Spain
12. IPD Sharing Statement
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Manipulative Therapy Techniques to Treat Chronic Low Back Pain
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