- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04384185
Combined Treatment of Manual Therapy and Therapeutic Exercise in Patients With Low Back Pain
Effectiveness of a Therapeutic Exercise Protocol Combined With Manual Therapy Techniques on the Diaphragm Muscle in Patients With Low Back Pain
MAIN OBJECTIVE: to assess whether an exercise protocol on the lumbar musculature by adding manual therapy techniques on the diaphragm muscle has the same or greater effect on chronic non-specific lumbar pain than an isolated exercise protocol.
SECONDARY OBJECTIVES: to evaluate the effectiveness of a lumbar exercise protocol in chronic non-specific low back pain in isolation; To evaluate the effectiveness of both therapies in improving joint range in patients with chronic non-specific low back pain and, finally, to assess catastrophism and the avoidance of lumbar mobility when carrying out loaded movements.
HYPOTHESIS: that a lumbar exercise protocol combined with manual therapy treatment on the diaphragm is equal or more effective on pain in patients with chronic nonspecific low back pain than treatment with the same lumbar exercise protocol in isolation.
Study Overview
Status
Intervention / Treatment
Detailed Description
METHODOLOGY: A prospective randomized clinical trial with two types of intervention (lumbar exercise protocol and manual diaphragm therapy) will be carried out. The variables to be measured are pain, disability, mobility and kinesiophobia. It will be performed in two groups of 21 people who are of legal age, who have low back pain of more than 3 months duration and which is of non-specific origin.
The patients will be randomized and divided into two groups A (control) and B (experimental).
Group A will undergo an exercise protocol.
Group B will undergo the same protocol plus manual therapy techniques on diaphragm muscle. Study participants will have treatment twice a week for 8 weeks, the first information session and the second measurement-evaluation session in the first week of treatment. In the following 3 weeks the session will last 40 minutes for both groups. In the 4th week the established measurements will be carried out again.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Madrid
-
Alcala de Henares, Madrid, Spain, 28871
- Grupo Fisioterapia y Dolor
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Legal age
- Non-specific Low-Back pain
- Pain more 3 months
Exclusion Criteria:
- subjects with lumbar herniation.
- Spine canal stenosis
- Subjects with neurological disease.
- Lumbar surgery
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Group A: Exercise therapy
Group A: will perform an exercise protocol to improve the stability of the spine muscle of low-back
|
Exercises:
|
Experimental: Group B. Manual therapy and exercises
Group B: Will be treated with manual therapy in the diaphragm muscle and the same protocol of therapeutic exercise applied in group A
|
Exercises:
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Low-back pain
Time Frame: Change from Baseline disability at 3 months
|
The investigators use a Visual Analog Scale (VAS) to determine the intensity of the patient with lowback pain.The VAS is a 100-mm line, oriented horizontally, with one end representing "no pain" and ten the other end representing "worst pain."
Subjects will be asked to rate their current pain with a mark on the scale.
|
Change from Baseline disability at 3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Disability with Oswestry Disability Index
Time Frame: Change from Baseline disability at 3 months
|
The Oswestry Disability Index (ODI) is a questionnaire used by clinicians and researchers to quantify disability for low back pain.The self-completed questionnaire contains ten topics concerning intensity of pain, lifting, ability to care for oneself, ability to walk, ability to sit, sexual function, ability to stand, social life, sleep quality, and ability to travel.Each topic category is followed by 6 statements describing different potential scenarios in the patient's life relating to the topic.
The patient then checks the statement which most closely resembles their situation.
Each question is scored on a scale of 0-5 with the first statement being zero and indicating the least amount of disability and the last statement is scored 5 indicating most severe disability.
The scores for all questions answered are summed, then multiplied by two to obtain the index (range 0 to 100).
Zero is equated with no disability and 100 is the maximum disability possible
|
Change from Baseline disability at 3 months
|
Lumbar range of motion
Time Frame: Change from Baseline disability at 3 months
|
Mobility.
It will be measured using an electronic inclinometer.The TiltMeter© -advanced level and inclinometer app is an inclinometer app of iPhone®.
The investigation has demonstrated that the app possesses good to excellent reliability (ICC ≥ 0.77) and concurrent validity with a gravity-based inclinometer (r ≥ 0.86) for measuring standing isolated lumbar flexion and extension range of movement
|
Change from Baseline disability at 3 months
|
Kinesiophobia
Time Frame: Change from Baseline disability at 3 months
|
Kinesiophobia was measured by an 11-item version of the Tampa Scale of Kinesiophobia (TSK-11).
The 11 items of the scale each have 4 response options; all anchored with the answers "strongly disagree", which scores 1 point, and "strongly agree", which scores 4 points.
The total sum score is calculated and can range between 11 and 44 points.
A high score indicates strong fear of movement/(re)injury, i.e. high kinesiophobia.
TSK-11 has been psychometrically evaluated and has shown good construct validity and reliability among older people (i.e.
internal consistency (Cronbach alpha, 0.74-0.87)
and test-retest reliability (ICC r = 0.747)
|
Change from Baseline disability at 3 months
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Tomas Gallego Izquierdo, PhD, Alcala University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CEIM/HU/2020/12
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Low Back Pain, Mechanical
-
Doha Ali Amin AhmedCairo UniversityRecruitingChronic Mechanical Low Back PainEgypt
-
Dow University of Health SciencesRecruitingLow Back Pain | Chronic Low-back Pain | Low Back Pain, Mechanical | Mechanical Low Back Pain | Pain, Chronic | Pain, Back | Lower Back Pain Chronic | CLBP - Chronic Low Back PainPakistan
-
University School of Physical Education in WroclawCompletedLow Back Pain | Low Back Pain, Mechanical | Low Back Pain, PosturalPoland
-
Benha UniversityNot yet recruiting
-
Youngstown State UniversityDuke UniversityNot yet recruitingLow Back Pain, Mechanical
-
Merit UniversityNot yet recruitingMechanical Low Back PainEgypt
-
Biruni UniversityCompletedLow Back Pain, MechanicalTurkey
-
Foundation University IslamabadEnrolling by invitationLow Back Pain, MechanicalPakistan
-
Bulent Ecevit UniversityCompleted
-
Riphah International UniversityCompletedMechanical Low Back PainPakistan
Clinical Trials on Exercise protocol
-
Universidade Federal de Sao CarlosRecruiting
-
Federal University of São PauloUnknownHeart Failure | Physical Activity | Transplant; Failure, HeartBrazil
-
University of Texas Southwestern Medical CenterWithdrawn
-
University of ValenciaRecruiting
-
Orthopedic Institute, Sioux Falls, SDCompletedFull Thickness Rotator Cuff TearUnited States
-
Grupo Rehabilitacion en SaludClinica Las AmericasCompletedChronic Heart FailureColombia
-
University of CalgaryHotchkiss Brain Institute, University of CalgaryCompletedBrain Injuries, Traumatic | Post-Concussion Syndrome | Mild Traumatic Brain Injury | Concussion, BrainCanada
-
University of MalagaMinistry of Science, Innovation and Universities, SpainNot yet recruiting
-
Wageningen UniversityGelderse Vallei HospitalUnknownMagnesium Deficiency
-
Boston Medical CenterBrigham and Women's HospitalWithdrawnAdhesive Capsulitis