Manipulative Therapy Techniques to Treat Chronic Low Back Pain

Not Applicable

Completed

• Conditions: Low Back Pain; Chronic Disease
• Interventions: Other: Functional Technique; Other: Manipulative Therapy Techniques

• Registration Number: NCT01796496
• Lead Sponsor: Universidad de Almeria

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.

Study Timeline

• Study First Submitted: 2013-02-20
• Study First Submitted QC: 2013-02-20
• Study First Posted: 2013-02-21
• Study Start: 2013-03
• Primary Completion: 2013-10
• Status Verified: 2013-11
• Study Completion: 2013-11
• Last Update Submitted: 2015-10-03
• Last Update Posted: 2015-10-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Functional Technique	Functional Technique	Manipulative Therapy Technique involves one technique on lumbar area. This protocol will be administered one a week for 3 weeks.
Manipulative Therapy Techniques	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.

Primary Outcome Measures

Name	Time	Method
Roland Morris Disability Questionnaire (RMDQ)	At baseline, 3 weeks and 7 weeks	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

Name	Time	Method
Lumbar Mobility in Flexion	At baseline, 3 weeks and 7 weeks	Lumbar mobility in flexion was determined by measuring the distance from the tip of the third finger to the floor with a tape measure.
Visual Analogue Scale (VAS)	At baseline, 3 weeks and 7 weeks	The visual analogue scale for pain intensity ranged from 0 = no pain to 10 = worst imaginable pain.
Tampa Scale for Kinesiophobia (TSK)	At baseline, 3 weeks and 7 weeks	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	At baseline, 3 weeks and 7 weeks	SF-36 Health Questionnaire scores range from 0 to 100% and indicate the self-perceived health-related quality of life.
Oswestry Disability Index (ODI)	At baseline, 3 weeks and 7 weeks	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%).
Isometric Resistance of Abdominal Muscles	At baseline, 3 weeks and 7 weeks	The McQuade test measures the isometric resistance of abdominal muscles in seconds.

Trial Locations

Locations (1)

Adelaida María Castro-Sánchez; 🇪🇸 Almeria, Spain