Musculoskeletal Disorder of the NeckNCT03622944
Effect of Exercise and Manuel Therapy Methods on Pain, Posture, Daily Living in People With Cervical Pathologies
A study testing Muscle Energy Technic, Deep Friction Massage and Exercise in people with Musculoskeletal Disorder of the Neck, run by Hacettepe University.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 65 years
- Conditions the study is for
- Musculoskeletal Disorder of the Neck
- What is being tested?
- Muscle Energy Technic, Deep Friction Massage and Exercise
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2015to 1 Oct 2016
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- clinical diagnosis of cervical disorder (for example; chronic neck pain, cervical disc herniation)
- must have pain at least three months.
Who cannot join
- History of structural scoliosis
- History of surgery
- History of metabolic, neurologic and metastatic diseases.
About this study
Official title: 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.
Read the 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.
- Conditions
- Musculoskeletal Disorder of the Neck
- Being tested
- Muscle Energy Technic, Deep Friction Massage, Exercise
- Keywords
- neck pain, physiotherapy, rehabilitation
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Muscle Energy TechnicProcedure or surgery
post isometric relaxation technics were applied to levator scapulae, trapezius, pectoralis muscles three sessions per week, totally six weeks.
Deep Friction MassageProcedure or surgery
deep friction massage was applied to cervical region included tendons, muscles and soft tissue.
ExerciseProcedure or surgery
spinal stabilization exercise were applied three sessions in a week totally six weeks.
| Study group | Role | What they receive |
|---|---|---|
| Muscle energy technic | Active comparator | post isometric relaxation technics were used as muscle energy technics. Receives: Procedure: Muscle Energy Technic; Procedure: Exercise |
| Deep Friction Massage | Active comparator | Painful areas palpated and deep friction massage was applied. Receives: Procedure: Deep Friction Massage; Procedure: Exercise |
| exercise | Active comparator | Physiotherapist guided Spinal stabilization exercises were applied. Receives: Procedure: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in pain sensitivity
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.
Measured: change from baseline PPT at six weeks
Secondary outcomes (5)
change in Light touch sensation
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.
Measured: change from baseline light touch sensation at six weeks
change in upper extremity disability
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.
Measured: Change from baseline disability at six weeks .
change in posture
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.
Measured: change from baseline posture at six weeks
change in perceived life quality
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.
Measured: change from baseline life quality at six weeks
change in functional disability
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.
Measured: change from baseline functional disability at six weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2018
- Study start1 Oct 2015
- Primary completion1 Mar 2016
- Study completion1 Oct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Musculoskeletal Disorder of the NeckStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aynur Demirel, Hacettepe University
- Investigators
- Aynur Demirel, PhD, Principal investigator, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03622944
- Sponsor's protocol ID
- GO15/564
- Status last verified
- Aug 2018
- First submitted
- 18 Jul 2018
- Last updated
- 9 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 24694684Carreon 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.
PubMed 20359958Persson 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.
PubMed 11374522Boyles 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.
PubMed 22851876
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Servikal bölge Patolojisi Olan Bireylerde Egzersiz ve Manuel Terapi yöntemlerinin ağrı, postür ve yaşam Kalitesi üzerindeki etkinliğinin Belirlenmesi
- ClinicalTrials.gov ID
- NCT03622944
- Acronym / sponsor ID
- GO15/564
- Conditions
- Musculoskeletal Disorder of the Neck
- Keywords
- neck pain, physiotherapy, rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 1 Oct 2015 (actual)
- Primary completion
- 1 Mar 2016 (actual)
- Study completion
- 1 Oct 2016 (actual)
- First posted
- 9 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Muscle energy technic | Active comparator | Procedure: Muscle Energy Technic, Procedure: Exercisepost isometric relaxation technics were used as muscle energy technics. |
| Deep Friction Massage | Active comparator | Procedure: Deep Friction Massage, Procedure: ExercisePainful areas palpated and deep friction massage was applied. |
| exercise | Active comparator | Procedure: ExercisePhysiotherapist guided Spinal stabilization exercises were applied. |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- clinical diagnosis of cervical disorder (for example; chronic neck pain, cervical disc herniation)
- must have pain at least three months.
Key exclusion criteria (3 listed)
- History of structural scoliosis
- History of surgery
- History of metabolic, neurologic and metastatic diseases.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Muscle Energy Technicpost isometric relaxation technics were applied to levator scapulae, trapezius, pectoralis muscles three sessions per week, totally six weeks. | Procedure or surgery | Muscle energy technic |
| Deep Friction Massagedeep friction massage was applied to cervical region included tendons, muscles and soft tissue. | Procedure or surgery | Deep Friction Massage |
| Exercisespinal stabilization exercise were applied three sessions in a week totally six weeks. | Procedure or surgery | Deep Friction Massage, Muscle energy technic, exercise |
Primary outcome
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.
5 secondary outcomes
change in Light touch sensation
Time frame: change from baseline light touch sensation at six weeks
change in upper extremity disability
Time frame: Change from baseline disability at six weeks .
change in posture
Time frame: change from baseline posture at six weeks
change in perceived life quality
Time frame: change from baseline life quality at six weeks
change in functional disability
Time frame: change from baseline functional disability at six weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2018.
- Results publication: PubMed 24694684Rihn 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.
- Results publication: PubMed 20359958Carreon 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.
- Results publication: PubMed 11374522Persson 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.
- Results publication: PubMed 22851876Boyles 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aynur Demirel, PhD principal investigator
Hacettepe University
Questions about this trial
What is this clinical trial studying?
A study testing Muscle Energy Technic, Deep Friction Massage and Exercise in people with Musculoskeletal Disorder of the Neck, run by Hacettepe University.
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 2 inclusion and 3 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 9 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
change in pain sensitivity (time frame: change from baseline PPT at six 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 NCT03622944, which also lists 4 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 9 Aug 2018.