- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03622944
Effect of Exercise and Manuel Therapy Methods on Pain, Posture, Daily Living in People With Cervical Pathologies
August 8, 2018 updated by: Aynur Demirel, Hacettepe University
Servikal bölge Patolojisi Olan Bireylerde Egzersiz ve Manuel Terapi yöntemlerinin ağrı, postür ve yaşam Kalitesi üzerindeki etkinliğinin Belirlenmesi
The aim of the study is to determine the effect of exercise and two different manual therapy methods on pain, quality of life and posture in people with neck pain.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Deep friction massage will use on cervical regions in first group, muscle energy technic will use second group and cervical stabilization exercise will use as an third group.
For all groups, pain intensity, Quality of life and posture will assess.
Study Type
Interventional
Enrollment (Actual)
45
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
25 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- clinical diagnosis of cervical disorder (for example; chronic neck pain, cervical disc herniation)
- must have pain at least three months.
Exclusion Criteria:
- History of structural scoliosis
- History of surgery
- History of metabolic, neurologic and metastatic diseases.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Muscle energy technic
post isometric relaxation technics were used as muscle energy technics.
|
post isometric relaxation technics were applied to levator scapulae, trapezius, pectoralis muscles three sessions per week, totally six weeks.
spinal stabilization exercise were applied three sessions in a week totally six weeks.
|
|
Active Comparator: Deep Friction Massage
Painful areas palpated and deep friction massage was applied.
|
spinal stabilization exercise were applied three sessions in a week totally six weeks.
deep friction massage was applied to cervical region included tendons, muscles and soft tissue.
|
|
Active Comparator: exercise
Physiotherapist guided Spinal stabilization exercises were applied.
|
spinal stabilization exercise were applied three sessions in a week totally six weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
change in pain sensitivity
Time Frame: change from baseline PPT at six weeks
|
pressure pain threshold (PPT) was measured with digital algometer.
Pressure pain threshold which identifies minimum levels increasing mechanical stimulus is gold standard method for measuring pain sensitivity.
PPT was measured from cervical vertebrae's spinous process and muscle belly's.
Algometer range was set 0 kgF to 12kgF.
Higher values represent increased pressure sensation.
|
change from baseline PPT at six weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
change in Light touch sensation
Time Frame: change from baseline light touch sensation at six weeks
|
Semmes weinstein monofilaments were used to determine light touch sensation.
It has twenty different evaluator size.
Evaluator size was started 2.83 point and higher values represent worse outcome.
Upper extremity dermatomes were tested.
|
change from baseline light touch sensation at six weeks
|
|
change in upper extremity disability
Time Frame: Change from baseline disability at six weeks .
|
The Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire was used.The questionnaire has 34 item which each item scored 1 to 5 points.
All responses summed and averaged.This value is then transformed to a score out of 100 by subtracting one and multiplying by 25.
This transformation is done to make the score easier to compare to other measures scaled on a 100 scale.
Minimum score is "0" and total score is "100".
higher values represent a worse outcome.
|
Change from baseline disability at six weeks .
|
|
change in posture
Time Frame: change from baseline posture at six weeks
|
Posture was assessed with global postural system.
This computer generated system has two cameras and lets three different plane postural assessment.
the assessments and postural deviation calculate with computer programme.
|
change from baseline posture at six weeks
|
|
change in perceived life quality
Time Frame: change from baseline life quality at six weeks
|
perceived quality of life was assessed with nottingham health profile.
the questionnaire has 38 questions in 6 subareas, with each question assigned a weighted value; the sum of all weighted values in a given subarea adds up to 100.
higher values represent better life quality.
|
change from baseline life quality at six weeks
|
|
change in functional disability
Time Frame: change from baseline functional disability at six weeks
|
Neck Disability Index (NDI) was used.NDI total scores ranged from 0 (no disability) to 50 (severe disability) which have ten items assessing perceived neck pain during daily living activities such as lifting, reading, driving, sleeping and recreational activities.
|
change from baseline functional disability at six weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Aynur Demirel, PhD, Hacettepe University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Boyles R, Toy P, Mellon J Jr, Hayes M, Hammer B. Effectiveness of manual physical therapy in the treatment of cervical radiculopathy: a systematic review. J Man Manip Ther. 2011 Aug;19(3):135-42. doi: 10.1179/2042618611Y.0000000011.
- Rihn JA, Radcliff K, Hipp J, Vaccaro AR, Hilibrand AS, Anderson DG, Albert TJ. Radiographic variables that may predict clinical outcomes in cervical disk replacement surgery. J Spinal Disord Tech. 2015 Apr;28(3):106-13. doi: 10.1097/BSD.0b013e31826a0c84.
- Carreon LY, Glassman SD, Campbell MJ, Anderson PA. Neck Disability Index, short form-36 physical component summary, and pain scales for neck and arm pain: the minimum clinically important difference and substantial clinical benefit after cervical spine fusion. Spine J. 2010 Jun;10(6):469-74. doi: 10.1016/j.spinee.2010.02.007. Epub 2010 Apr 1.
- Persson LC, Lilja A. Pain, coping, emotional state and physical function in patients with chronic radicular neck pain. A comparison between patients treated with surgery, physiotherapy or neck collar--a blinded, prospective randomized study. Disabil Rehabil. 2001 May 20;23(8):325-35. doi: 10.1080/09638280010005567.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2015
Primary Completion (Actual)
March 1, 2016
Study Completion (Actual)
October 1, 2016
Study Registration Dates
First Submitted
July 18, 2018
First Submitted That Met QC Criteria
August 8, 2018
First Posted (Actual)
August 9, 2018
Study Record Updates
Last Update Posted (Actual)
August 9, 2018
Last Update Submitted That Met QC Criteria
August 8, 2018
Last Verified
August 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- GO15/564
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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.
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