Manipulative Therapy Techniques to Treat Chronic Low Back Pain
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|ClinicalTrials.gov Identifier: NCT01796496|
Recruitment Status : Completed
First Posted : February 21, 2013
Last Update Posted : October 6, 2015
|Condition or disease||Intervention/treatment|
|Low Back Pain Chronic Disease||Other: Manipulative Therapy Techniques Other: Functional Technique|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||62 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Short-term Effect of Manipulative Therapy Techniques in People With Chronic Low Back Pain: A Randomized Controlled Trial.|
|Study Start Date :||March 2013|
|Primary Completion Date :||October 2013|
|Study Completion Date :||November 2013|
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.
- Roland Morris Disability Questionnaire (RMDQ) [ Time Frame: 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.
- Oswestry Disability Index (ODI) [ Time Frame: 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%).
- Visual Analogue Scale (VAS) [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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.
- Isometric Resistance of Abdominal Muscles [ Time Frame: At baseline, 3 weeks and 7 weeks ]The McQuade test measures the isometric resistance of abdominal muscles in seconds.
- Lumbar Mobility in Flexion [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01796496
|Adelaida María Castro-Sánchez|
|Almeria, Spain, 04120|
|Study Director:||Adelaida M Castro-Sánchez, PhD||Universidad de Almeria|