Manipulative Therapy Techniques to Treat Chronic Low Back Pain

Low Back Pain Clinical Trial

Official title:

Short-term Effect of Manipulative Therapy Techniques in People With Chronic Low Back Pain: A Randomized Controlled Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01796496
• Other study ID #: UAL-1
• Status: Completed
• Phase: N/A
• First received: February 20, 2013
• Last updated: October 3, 2015
• Start date: March 2013
• Est. completion date: November 2013

Study information

• Verified date: November 2013
• Source: Universidad de Almeria
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to analyze the effectiveness of a three manipulative therapy techniques in People with Chronic Low Back Pain.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: November 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 25 Years to 55 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Back Pain
• Chronic Disease
• Low Back Pain

Intervention

Other:
• Manipulative Therapy Techniques
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.
• 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.

Locations

Country	Name	City	State
Spain	Adelaida María Castro-Sánchez	Almeria

Sponsors (3)

Lead Sponsor	Collaborator
Universidad de Almeria	Universidad de Granada, Universidad Rey Juan Carlos

Country where clinical trial is conducted

Spain, 

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* Note: There are 26 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	At baseline, 3 weeks and 7 weeks	No
Secondary	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%).	At baseline, 3 weeks and 7 weeks	No
Secondary	Visual Analogue Scale (VAS)	The visual analogue scale for pain intensity ranged from 0 = no pain to 10 = worst imaginable pain.	At baseline, 3 weeks and 7 weeks	No
Secondary	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".	At baseline, 3 weeks and 7 weeks	No
Secondary	Quality of Life	SF-36 Health Questionnaire scores range from 0 to 100% and indicate the self-perceived health-related quality of life.	At baseline, 3 weeks and 7 weeks	No
Secondary	Isometric Resistance of Abdominal Muscles	The McQuade test measures the isometric resistance of abdominal muscles in seconds.	At baseline, 3 weeks and 7 weeks	No
Secondary	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.	At baseline, 3 weeks and 7 weeks	No