Effect of Exercise and Manuel Therapy Methods on Pain, Posture, Daily Living in People With Cervical Pathologies

• ClinicalTrials.gov Identifier: NCT03622944
• Recruitment Status: Completed
• First Posted: August 9, 2018
• Last Update Posted: August 9, 2018
• Sponsor: Hacettepe University
• Information provided by (Responsible Party): Aynur Demirel, Hacettepe University

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Musculoskeletal Disorder of the Neck	Procedure: Muscle Energy Technic; Procedure: Deep Friction Massage; Procedure: Exercise	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 45 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Servikal bölge Patolojisi Olan Bireylerde Egzersiz ve Manuel Terapi yöntemlerinin ağrı, postür ve yaşam Kalitesi üzerindeki etkinliğinin Belirlenmesi
• Actual Study Start Date: October 1, 2015
• Actual Primary Completion Date: March 1, 2016
• Actual Study Completion Date: October 1, 2016

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Muscle energy technic; post isometric relaxation technics were used as muscle energy technics.	Procedure: Muscle Energy Technic; post isometric relaxation technics were applied to levator scapulae, trapezius, pectoralis muscles three sessions per week, totally six weeks.; Procedure: Exercise; 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.	Procedure: Deep Friction Massage; deep friction massage was applied to cervical region included tendons, muscles and soft tissue.; Procedure: Exercise; spinal stabilization exercise were applied three sessions in a week totally six weeks.
Active Comparator: exercise; Physiotherapist guided Spinal stabilization exercises were applied.	Procedure: Exercise; spinal stabilization exercise were applied three sessions in a week totally six weeks.

Outcome Measures

Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. 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.
2. 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.
3. 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.
4. 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.
5. 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.

Eligibility Criteria

• Ages Eligible for Study: 25 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Sponsors and Collaborators

Hacettepe University

Investigators

• Principal Investigator: Aynur Demirel, PhD; Hacettepe University

More Information

Publications of Results:

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.

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.

• Responsible Party: Aynur Demirel, Principal Investigator, Hacettepe University
• ClinicalTrials.gov Identifier: NCT03622944
• Other Study ID Numbers: GO15/564
• First Posted: August 9, 2018
• Last Update Posted: August 9, 2018
• Last Verified: August 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Keywords provided by Aynur Demirel, Hacettepe University:

neck pain; physiotherapy; rehabilitation

Additional relevant MeSH terms:

Musculoskeletal Diseases