Neck Pain MusculoskeletalPhase 2NCT02424032
Stabilization Exercises With and Without Connective Tissue Massage for Chronic Mechanical Neck Pain
A Phase 2 study testing "Exercise" and "connective tissue massage" and "Exercise" in people with Neck Pain Musculoskeletal, run by Seyda TOPRAK CELENAY at 2 sites in Turkey (Türkiye).
Trial summary
The aim of this study was to investigate and compared the effects of cervical and scapulothoracic stabilization exercises with and without connective tissue massage (CTM) for patients with chronic mechanical neck pain. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Neck Pain Musculoskeletal
- What is being tested?
- "Exercise" and "connective tissue massage" and "Exercise"
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- Feb 2013to May 2015
- Phase
- Phase 2
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 to 65 years of age,
- having neck pain for more than 3 months, and
- being volunteer
Who cannot join
- Stenosis,
- traumatic injury history,
- previous surgery related to cervical spine,
- hypermobility,
- cancer,
- having inflammatory rheumatologic,
Show all 9Show fewer
- severe psychological disorders,
- being pregnant, and
- intervention including exercise or physical therapy in the last 3 months
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites, 2 recruiting
- Recruiting
Ataturk Trainning and Research Hospital
Ankara, Cankaya, 06800
Seyda - TOPRAK CELENAY, Assist. Prof, +90 0534 041 39 86, sydtoprak@hotmail.com
Derya - OZER KAYA, Assoc. Prof, +90 232 329 35 13 ext. 4711, deryaozer2000@yahoo.com
- Recruiting
Ataturk Trainning and Research Hospital
Ankara, Cankaya
Seyda TOPRAK CELENAY, 490-534-041-3986, sydtoprak@hotmail.com
About this study
The aim of this study was to investigate and compared the effects of cervical and scapulothoracic stabilization exercises with and without connective tissue massage (CTM) for patients with chronic mechanical neck pain.
Read the detailed description
Sixty patients with chronic mechanical neck pain were recruited and randomly allocated into stabilization exercise with and without the connective tissue massage program. The study's inclusion criteria were as follows: 18 to 65 years of age, having neck pain for more than 3 months, and being volunteer. The exclusion criteria were as follows: stenosis, traumatic injury history, previous surgery related to cervical spine, hypermobility, cancer, having inflammatory rheumatologic, severe psychological disorders, being pregnant, and intervention including exercise or physical therapy in the last 3 months.The program was carried out for 12 sessions, 3 days/week in 4 weeks. Pain intensity with Visual Analog Scale, pressure pain threshold with digital algometer, the level of anxiety with the Spielberger State Trait Anxiety Inventory, and life quality with Short Form-36 were evaluated before and after treatment.
- Conditions
- Neck Pain Musculoskeletal
- Being tested
- "Exercise" and "connective tissue massage", "Exercise"
- Keywords
- Neck pain, stabilization exercise, connective tissue massage
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"Exercise" and "connective tissue massage"Behavioural
Cervical and scapulothoracic stabilization exercises with connective tissue massage were performed.The program was carried out for 12 sessions, 3 days/week in 4 weeks.
"Exercise"Behavioural
Cervical and scapulothoracic stabilization exercises were performed. The program was carried out for 12 sessions, 3 days/week in 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Exercise and connective tissue massage | Experimental | Stabilization exercise and connective tissue massage have been applied Receives: Behavioral: "Exercise" and "connective tissue massage" |
| Exercise | Active comparator | Only stabilization exercise has been applied Receives: Behavioral: "Exercise" |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Neck pain intensity as measured by Visual Analog Scale
Measured: Change from baseline neck pain intensity at 4 weeks
Secondary outcomes (3)
Change in level of anxiety as assessed by Spielberger State Trait Anxiety Inventory
Measured: Change from baseline level of anxiety at 4 weeks
Change in quality of life as assessed by Short Form-36
Measured: Change from baseline quality of life at 4 weeks
Change in pressure pain threshold as measured by digital algometer
Measured: Change from baseline pressure pain threshold at 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2015 (estimated)
- Study startFeb 2013
- Primary completionMay 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Neck Pain MusculoskeletalStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 53 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seyda TOPRAK CELENAY
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Seyda TOPRAK CELENAY, Ataturk Training and Research Hospital
- Investigators
- Seyda TOPRAK CELENAY, Principal investigator, Ataturk Trainning and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02424032
- Sponsor's protocol ID
- GO 13/381
- Status last verified
- Apr 2015
- First submitted
- 8 Apr 2015
- Last updated
- 22 Apr 2015
- Results posted
- No
Publications
Bakar Y, Sertel M, Ozturk A, Yumin ET, Tatarli N, Ankarali H. Short term effects of classic massage compared to connective tissue massage on pressure pain threshold and muscle relaxation response in women with chronic neck pain: a preliminary study. J Manipulative Physiol Ther. 2014 Jul-Aug;37(6):415-21. doi: 10.1016/j.jmpt.2014.05.004. Epub 2014 Aug 6.
PubMed 25108749Dusunceli Y, Ozturk C, Atamaz F, Hepguler S, Durmaz B. Efficacy of neck stabilization exercises for neck pain: a randomized controlled study. J Rehabil Med. 2009 Jul;41(8):626-31. doi: 10.2340/16501977-0392.
PubMed 19565156Jull G, Trott P, Potter H, Zito G, Niere K, Shirley D, Emberson J, Marschner I, Richardson C. A randomized controlled trial of exercise and manipulative therapy for cervicogenic headache. Spine (Phila Pa 1976). 2002 Sep 1;27(17):1835-43; discussion 1843. doi: 10.1097/00007632-200209010-00004.
PubMed 12221344Sherman KJ, Cherkin DC, Hawkes RJ, Miglioretti DL, Deyo RA. Randomized trial of therapeutic massage for chronic neck pain. Clin J Pain. 2009 Mar-Apr;25(3):233-8. doi: 10.1097/AJP.0b013e31818b7912.
PubMed 19333174Celenay ST, Kaya DO, Akbayrak T. Cervical and scapulothoracic stabilization exercises with and without connective tissue massage for chronic mechanical neck pain: A prospective, randomised controlled trial. Man Ther. 2016 Feb;21:144-50. doi: 10.1016/j.math.2015.07.003. Epub 2015 Jul 15.
PubMed 26211422
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stabilization Exercises With and Without Connective Tissue Massage for Chronic Mechanical Neck Pain
- ClinicalTrials.gov ID
- NCT02424032
- Acronym / sponsor ID
- GO 13/381
- Conditions
- Neck Pain Musculoskeletal
- Keywords
- Neck pain, stabilization exercise, connective tissue massage
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 53 participants (estimated)
- Lead sponsor
- Seyda TOPRAK CELENAYUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- May 2015 (estimated)
- First posted
- 22 Apr 2015 (estimated)
- 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 this study was to investigate and compared the effects of cervical and scapulothoracic stabilization exercises with and without connective tissue massage (CTM) for patients with chronic mechanical neck pain.
Detailed description
Sixty patients with chronic mechanical neck pain were recruited and randomly allocated into stabilization exercise with and without the connective tissue massage program. The study's inclusion criteria were as follows: 18 to 65 years of age, having neck pain for more than 3 months, and being volunteer. The exclusion criteria were as follows: stenosis, traumatic injury history, previous surgery related to cervical spine, hypermobility, cancer, having inflammatory rheumatologic, severe psychological disorders, being pregnant, and intervention including exercise or physical therapy in the last 3 months.The program was carried out for 12 sessions, 3 days/week in 4 weeks. Pain intensity with Visual Analog Scale, pressure pain threshold with digital algometer, the level of anxiety with the Spielberger State Trait Anxiety Inventory, and life quality with Short Form-36 were evaluated before and after treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise and connective tissue massage | Experimental | Behavioral: "Exercise" and "connective tissue massage"Stabilization exercise and connective tissue massage have been applied |
| Exercise | Active comparator | Behavioral: "Exercise"Only stabilization exercise has been applied |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 to 65 years of age,
- having neck pain for more than 3 months, and
- being volunteer
Key exclusion criteria (9 listed)
- Stenosis,
- traumatic injury history,
- previous surgery related to cervical spine,
- hypermobility,
- cancer,
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 |
|---|---|---|
| "Exercise" and "connective tissue massage"Cervical and scapulothoracic stabilization exercises with connective tissue massage were performed.The program was carried out for 12 sessions, 3 days/week in 4 weeks. | Behavioural | Exercise and connective tissue massage |
| "Exercise"Cervical and scapulothoracic stabilization exercises were performed. The program was carried out for 12 sessions, 3 days/week in 4 weeks. | Behavioural | Exercise |
Primary outcome
Change in Neck pain intensity as measured by Visual Analog Scale
Time frame: Change from baseline neck pain intensity at 4 weeks
3 secondary outcomes
Change in level of anxiety as assessed by Spielberger State Trait Anxiety Inventory
Time frame: Change from baseline level of anxiety at 4 weeks
Change in quality of life as assessed by Short Form-36
Time frame: Change from baseline quality of life at 4 weeks
Change in pressure pain threshold as measured by digital algometer
Time frame: Change from baseline pressure pain threshold at 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2015.
- Results publication: PubMed 25108749Bakar Y, Sertel M, Ozturk A, Yumin ET, Tatarli N, Ankarali H. Short term effects of classic massage compared to connective tissue massage on pressure pain threshold and muscle relaxation response in women with chronic neck pain: a preliminary study. J Manipulative Physiol Ther. 2014 Jul-Aug;37(6):415-21. doi: 10.1016/j.jmpt.2014.05.004. Epub 2014 Aug 6.
- Results publication: PubMed 19565156Dusunceli Y, Ozturk C, Atamaz F, Hepguler S, Durmaz B. Efficacy of neck stabilization exercises for neck pain: a randomized controlled study. J Rehabil Med. 2009 Jul;41(8):626-31. doi: 10.2340/16501977-0392.
- Results publication: PubMed 12221344Jull G, Trott P, Potter H, Zito G, Niere K, Shirley D, Emberson J, Marschner I, Richardson C. A randomized controlled trial of exercise and manipulative therapy for cervicogenic headache. Spine (Phila Pa 1976). 2002 Sep 1;27(17):1835-43; discussion 1843. doi: 10.1097/00007632-200209010-00004.
- Results publication: PubMed 19333174Sherman KJ, Cherkin DC, Hawkes RJ, Miglioretti DL, Deyo RA. Randomized trial of therapeutic massage for chronic neck pain. Clin J Pain. 2009 Mar-Apr;25(3):233-8. doi: 10.1097/AJP.0b013e31818b7912.
- Derived from this study: PubMed 26211422Celenay ST, Kaya DO, Akbayrak T. Cervical and scapulothoracic stabilization exercises with and without connective tissue massage for chronic mechanical neck pain: A prospective, randomised controlled trial. Man Ther. 2016 Feb;21:144-50. doi: 10.1016/j.math.2015.07.003. Epub 2015 Jul 15.
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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.
Seyda TOPRAK CELENAY principal investigator
Ataturk Trainning and Research Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing "Exercise" and "connective tissue massage" and "Exercise" in people with Neck Pain Musculoskeletal, run by Seyda TOPRAK CELENAY at 2 sites in Turkey (Türkiye).
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 3 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 22 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Seyda TOPRAK CELENAY (+90-534-041-3986, sydtoprak@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Neck pain intensity as measured by Visual Analog Scale (time frame: Change from baseline neck pain intensity at 4 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 NCT02424032, which also lists 5 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 22 Apr 2015.