AzTrials
AzTrials

Low Back PainNCT01796496

Manipulative Therapy Techniques to Treat Chronic Low Back Pain

A study testing Manipulative Therapy Techniques and Functional Technique in people with Low Back Pain and Chronic Disease, run by Universidad de Almeria at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 25 to 55 years
Conditions the study is for
Low Back Pain, Chronic Disease
What is being tested?
Manipulative Therapy Techniques and Functional Technique
Could I receive a placebo?
No, everyone receives an active treatment
How many people
62 participants
Where
1 siteSpain
Study dates
Mar 2013to Nov 2013
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 25 to 55 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Spain1 site
  • Adelaida María Castro-Sánchez

    Almería, Almeria, 04120

Other trials in Spain

About this study

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

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

Read the 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.

Being tested
Manipulative Therapy Techniques, Functional Technique
Keywords
Low back pain., Manipulative therapy techniques., Randomized controlled trial., Chronic pain.
Medical subject headings
Low Back Pain, Chronic Disease, Chronic Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Manipulative Therapy TechniquesOther

    • 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 TechniqueOther

    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.

Study groups in NCT01796496
Study groupRoleWhat they receive
Manipulative Therapy TechniquesExperimentalManipulative Therapy Techniques involve three techniques on lumbar and sacral areas. This protocol will be administered one a week for 3 weeks.
Receives: Other: Manipulative Therapy Techniques
Functional TechniqueActive comparatorManipulative Therapy Technique involves one technique on lumbar area. This protocol will be administered one a week for 3 weeks.
Receives: Other: Functional Technique

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: At baseline, 3 weeks and 7 weeks

Secondary outcomes (6)
  1. 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%).

    Measured: At baseline, 3 weeks and 7 weeks

  2. Visual Analogue Scale (VAS)

    The visual analogue scale for pain intensity ranged from 0 = no pain to 10 = worst imaginable pain.

    Measured: At baseline, 3 weeks and 7 weeks

  3. 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".

    Measured: At baseline, 3 weeks and 7 weeks

  4. Quality of Life

    SF-36 Health Questionnaire scores range from 0 to 100% and indicate the self-perceived health-related quality of life.

    Measured: At baseline, 3 weeks and 7 weeks

  5. Isometric Resistance of Abdominal Muscles

    The McQuade test measures the isometric resistance of abdominal muscles in seconds.

    Measured: At baseline, 3 weeks and 7 weeks

  6. 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.

    Measured: At baseline, 3 weeks and 7 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Feb 2013 (estimated)
  2. Study startMar 2013
  3. Primary completionOct 2013
  4. Study completionNov 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
62 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01796496
Sponsor's protocol ID
UAL-1
Status last verified
Nov 2013
First submitted
20 Feb 2013
Last updated
6 Oct 2015
Results posted
No
Data monitoring committee
No

Publications

  • Schafer A, Gartner-Tschacher N, Schottker-Koniger T. [Subgroup-specific therapy of low back pain: description and validity of two classification systems]. Orthopade. 2013 Feb;42(2):90-9. doi: 10.1007/s00132-012-2041-5. German.

    PubMed 23370728
  • Rodeghero JR, Denninger TR, Ross MD. Abdominal pain in physical therapy practice: 3 patient cases. J Orthop Sports Phys Ther. 2013 Feb;43(2):44-53. doi: 10.2519/jospt.2013.4408. Epub 2013 Jan 14.

    PubMed 23322025
  • Muir JM. Partial lumbosacral transitional vertebrae: 2 cases of unilateral sacralization. J Chiropr Med. 2012 Jun;11(2):77-83. doi: 10.1016/j.jcm.2011.12.002.

    PubMed 23204950
  • Shum GL, Tsung BY, Lee RY. The immediate effect of posteroanterior mobilization on reducing back pain and the stiffness of the lumbar spine. Arch Phys Med Rehabil. 2013 Apr;94(4):673-9. doi: 10.1016/j.apmr.2012.11.020. Epub 2012 Nov 23.

    PubMed 23178541
  • Falco FJ, Manchikanti L, Datta S, Sehgal N, Geffert S, Onyewu O, Zhu J, Coubarous S, Hameed M, Ward SP, Sharma M, Hameed H, Singh V, Boswell MV. An update of the effectiveness of therapeutic lumbar facet joint interventions. Pain Physician. 2012 Nov-Dec;15(6):E909-53.

    PubMed 23159980
  • Williams JM, Haq I, Lee RY. The effect of pain relief on dynamic changes in lumbar curvature. Man Ther. 2013 Apr;18(2):149-54. doi: 10.1016/j.math.2012.09.004. Epub 2012 Oct 9.

    PubMed 23058448
  • Williams JM, Haq I, Lee RY. A novel approach to the clinical evaluation of differential kinematics of the lumbar spine. Man Ther. 2013 Apr;18(2):130-5. doi: 10.1016/j.math.2012.08.003. Epub 2012 Oct 6.

    PubMed 23047044
  • Hendrick P, Mani R, Bishop A, Milosavljevic S, Schneiders AG. Therapist knowledge, adherence and use of low back pain guidelines to inform clinical decisions--a national survey of manipulative and sports physiotherapists in New Zealand. Man Ther. 2013 Apr;18(2):136-42. doi: 10.1016/j.math.2012.09.002. Epub 2012 Oct 6.

    PubMed 23047043
  • Cook C, Learman K, Showalter C, Kabbaz V, O'Halloran B. Early use of thrust manipulation versus non-thrust manipulation: a randomized clinical trial. Man Ther. 2013 Jun;18(3):191-8. doi: 10.1016/j.math.2012.08.005. Epub 2012 Oct 2.

    PubMed 23040656
  • Carlsson H, Rasmussen-Barr E. Clinical screening tests for assessing movement control in non-specific low-back pain. A systematic review of intra- and inter-observer reliability studies. Man Ther. 2013 Apr;18(2):103-10. doi: 10.1016/j.math.2012.08.004. Epub 2012 Sep 25.

    PubMed 23018080
  • Rubinstein SM, Terwee CB, Assendelft WJ, de Boer MR, van Tulder MW. Spinal manipulative therapy for acute low-back pain. Cochrane Database Syst Rev. 2012 Sep 12;2012(9):CD008880. doi: 10.1002/14651858.CD008880.pub2.

    PubMed 22972127
  • Marlowe D. Complementary and alternative medicine treatments for low back pain. Prim Care. 2012 Sep;39(3):533-46. doi: 10.1016/j.pop.2012.06.008. Epub 2012 Jul 30.

    PubMed 22958563
  • Guild DG. Mechanical therapy for low back pain. Prim Care. 2012 Sep;39(3):511-6. doi: 10.1016/j.pop.2012.06.006.

    PubMed 22958560
  • Balthazard P, de Goumoens P, Rivier G, Demeulenaere P, Ballabeni P, Deriaz O. Manual therapy followed by specific active exercises versus a placebo followed by specific active exercises on the improvement of functional disability in patients with chronic non specific low back pain: a randomized controlled trial. BMC Musculoskelet Disord. 2012 Aug 28;13:162. doi: 10.1186/1471-2474-13-162.

    PubMed 22925609
  • Tufo A, Desai GJ, Cox WJ. Psoas syndrome: a frequently missed diagnosis. J Am Osteopath Assoc. 2012 Aug;112(8):522-8. doi: 10.7556/jaoa.2012.112.8.522.

    PubMed 22904251

Questions about this trial

What is this clinical trial studying?

A study testing Manipulative Therapy Techniques and Functional Technique in people with Low Back Pain and Chronic Disease, run by Universidad de Almeria at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Roland Morris Disability Questionnaire (RMDQ) (time frame: At baseline, 3 weeks and 7 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01796496, which also lists 26 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2015.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in