Manipulative Therapy Techniques to Treat Chronic Low Back Pain

This study has been completed.
Sponsor:
Collaborators:
Universidad de Granada
Universidad Rey Juan Carlos
Information provided by (Responsible Party):
Adelaida María Castro-Sánchez, Universidad de Almeria
ClinicalTrials.gov Identifier:
NCT01796496
First received: February 20, 2013
Last updated: November 5, 2013
Last verified: November 2013
  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.

Resource links provided by NLM:


Further study details as provided by Universidad de Almeria:

Primary Outcome Measures:
  • Roland Morris Disability Questionnaire (RMDQ) [ Time Frame: At baseline, 3 weeks and 7 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.


Secondary Outcome Measures:
  • Oswestry Disability Index (ODI) [ Time Frame: At baseline, 3 weeks and 7 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, 3 weeks and 7 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, 3 weeks and 7 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, 3 weeks and 7 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, 3 weeks and 7 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, 3 weeks and 7 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.


Enrollment: 62
Study Start Date: March 2013
Study Completion Date: November 2013
Primary Completion Date: October 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
  • 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.
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
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01796496

Locations
Spain
Adelaida María Castro-Sánchez
Almeria, Spain, 04120
Sponsors and Collaborators
Universidad de Almeria
Universidad de Granada
Universidad Rey Juan Carlos
Investigators
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: November 5, 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
Low Back Pain
Chronic Disease
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on September 18, 2014