Clinical trial NCT04354194: Osteopathic Manipulative Treatment in Chronic Non-specific Neck Pain
Official title: Osteopathic Manipulative Treatment in Chronic Non-specific Neck Pain: A Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Pain
Keywords: Osteopathic Manipulative Treatment
Chronic Non-spesific Neck Pain
Conventional Therapy
Lead sponsor: Pamukkale University
Sponsor class: OTHER
First posted: 2020-04-21
Enrollment: 120
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to investigate the effect of osteopathic manipulative treatment on pain intensity, disability level and psychosocial factors in patients with chronic non-specific neck pain. We hypothesed that osteopathic manipulative treatment is better than conventional physiotherapy in management of pain, disability and depression.

Detailed description: This study will conduct between April 2020 and July 2020 at Denizli State Hospital. Participants who were diagnosed as chronic non-specific neck pain by a specialist physician will include the study. They will treated at physical therapy clinic. Inclussion criteria will; participants diagnosed as non-specific neck pain by the physician and Non-spesific neck pain at least 3 months. Exclussion criteria were; participants who have had surgery or are indicated for surgery, participants who have had exercise therapy and / or physical therapy in the last 1 year with a history of trauma to the cervical region, participants who have had neck pain that develop due to a particular cause such as tumor, compression fracture, metastasis and infection. According to power analysis, 102 participant will include the study with 95% coincidence interval and 80% power. Participants will be divided into 2 groups. Randomization method will be closed envelope. Group 1 will receive Conventional Physiotherapy Programme (CP), Group 2 will receive Osteopathin Manipulative Treatment (OMT). Pain Intensity at rest and activity, psychological state( Beck Depression Inventory) and Disability level (Neck Disability Index) will assess at baseline and 3 weeks.

Eligibility criteria: Inclusion Criteria:

* participants diagnosed as non-specific neck pain by the physician.
* Non-spesific neck pain at least 3 months.

Exclusion Criteria:

* participants who have had surgery or are indicated for surgery
* participants who have had exercise therapy and / or physical therapy in the last 1 year with a history of trauma to the cervical region
* participants who have had neck pains that develop due to a particular cause such as tumor, compression fracture, metastasis and infection

Primary outcomes:
measure: Pain Intensity
timeFrame: Change from baseline pain intensity at 3 weeks
Secondary outcomes:
measure: Disability level
timeFrame: Change from baseline Neck Disability Index score at 3 weeks
measure: Depression level
timeFrame: Change from baseline Beck Depression Inventory score at 3 weeks
Other outcomes:
Locations:
city: Denizli
country: Turkey
facility: Denizli State Hospital
Study officials:
affiliation: Pamukkale University
name: Nesrin Yağcı, Prof.
role: STUDY_DIRECTOR
References:
citation: Schwerla F, Bischoff A, Nurnberger A, Genter P, Guillaume JP, Resch KL. Osteopathic treatment of patients with chronic non-specific neck pain: a randomised controlled trial of efficacy. Forsch Komplementmed. 2008 Jun;15(3):138-45. doi: 10.1159/000132397. Epub 2008 Jun 4.
citation: Jarski RW, Loniewski EG, Williams J, Bahu A, Shafinia S, Gibbs K, Muller M. The effectiveness of osteopathic manipulative treatment as complementary therapy following surgery: a prospective, match-controlled outcome study. Altern Ther Health Med. 2000 Sep;6(5):77-81.
citation: Edwards DJ, Toutt C. An evaluation of osteopathic treatment on psychological outcomes with patients suffering from chronic pain: A prospective observational cohort study collected through a health and well-being academy. Health Psychol Open. 2018 May 10;5(1):2055102918774684. doi: 10.1177/2055102918774684. eCollection 2018 Jan-Jun.
citation: Verhaeghe N, Schepers J, van Dun P, Annemans L. Osteopathic care for low back pain and neck pain: A cost-utility analysis. Complement Ther Med. 2018 Oct;40:207-213. doi: 10.1016/j.ctim.2018.06.001. Epub 2018 Jun 9.