Manipulative Therapy Techniques to Treat Chronic Low Back Pain
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Purpose
The purpose of this study is to analyze the effectiveness of a three manipulative therapy techniques in People with Chronic Low Back Pain.
| Condition | Intervention |
|---|---|
|
Low Back Pain Chronic Disease |
Other: Manipulative Therapy Techniques Other: Functional Technique |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | Short-term Effect of Manipulative Therapy Techniques in People With Chronic Low Back Pain: A Randomized Controlled Trial. |
- Roland Morris Disability Questionnaire (RMDQ) [ Time Frame: At baseline and 3 weeks ] [ Designated as safety issue: No ]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.
- Oswestry Disability Index (ODI) [ Time Frame: At baseline and 3 weeks ] [ Designated as safety issue: No ]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) [ Time Frame: At baseline and 3 weeks ] [ Designated as safety issue: No ]The visual analogue scale for pain intensity ranged from 0 = no pain to 10 = worst imaginable pain.
- Tampa Scale for Kinesiophobia (TSK) [ Time Frame: At baseline and 3 weeks ] [ Designated as safety issue: No ]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 [ Time Frame: At baseline and 3 weeks ] [ Designated as safety issue: No ]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 [ Time Frame: At baseline and 3 weeks ] [ Designated as safety issue: No ]The McQuade test measures the isometric resistance of abdominal muscles in seconds.
- Lumbar Mobility in Flexion [ Time Frame: At baseline and 3 weeks ] [ Designated as safety issue: No ]Lumbar mobility in flexion was determined by measuring the distance from the tip of the third finger to the floor with a tape measure.
| Estimated Enrollment: | 62 |
| Study Start Date: | March 2013 |
| Estimated Study Completion Date: | May 2013 |
| Estimated Primary Completion Date: | May 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Manipulative Therapy Techniques
Manipulative Therapy Techniques involve three techniques on lumbar and sacral areas. This protocol will be administered one a week for 3 weeks.
|
Other: Manipulative Therapy Techniques
|
|
Active Comparator: Functional Technique
Manipulative Therapy Technique involves one technique on lumbar area. This protocol will be administered one a week for 3 weeks.
|
Other: Functional Technique
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.
|
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.
Eligibility| Ages Eligible for Study: | 25 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations| Spain | |
| Adelaida María Castro-Sánchez | |
| Almeria, Spain, 04120 | |
| Study Director: | Adelaida M Castro-Sánchez, PhD | University of Almeria |
More Information
Publications:
| Responsible Party: | Adelaida María Castro-Sánchez, Lecturer-PhD, Universidad de Almeria |
| ClinicalTrials.gov Identifier: | NCT01796496 History of Changes |
| Other Study ID Numbers: | UAL-1 |
| Study First Received: | February 20, 2013 |
| Last Updated: | April 17, 2013 |
| Health Authority: | Spain: Ethics Committee |
Keywords provided by Universidad de Almeria:
|
Low back pain. Manipulative therapy techniques. Randomized controlled trial. Chronic pain. |
Additional relevant MeSH terms:
|
Back Pain Chronic Disease Low Back Pain Pain Neurologic Manifestations |
Nervous System Diseases Signs and Symptoms Disease Attributes Pathologic Processes |
ClinicalTrials.gov processed this record on June 17, 2013