Osteopathic Manipulative Treatment in Chronic Non-specific Neck Pain

Chronic Pain Clinical Trial

Official title:

Osteopathic Manipulative Treatment in Chronic Non-specific Neck Pain: A Controlled Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04354194
• Other study ID #: 21.05.2019/10
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2020
• Est. completion date: December 20, 2020

Study information

• Verified date: June 2020
• Source: Pamukkale University
• Contact: Sule Simsek, Phd
• Phone: +905058099914
• Email: sules[@]pau.edu.tr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: December 20, 2020
• Est. primary completion date: September 20, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain
• Neck Pain

Intervention

Procedure:
• Conventional Physiotherapy
Conventional Physiotherapy consist of Hotpacks, TENS and US.The participants were positioned in sitting and supported with a pillow under the head, 20 min hot pack was applied. Therapatic Ultrason were applied with the frequency of 1 MHz, intensity of 1,5 watt/cm² and duration of 5 minute. TENS was applied to the cervical region with 2-channel, 4 surface electrodes at 60-120 Hz, and 50-100 pulse duration for 20 minutes.
• Osteopathic Manupilative Treatment
Osteopathic Manupilative Treatment consist of stretching the fascia to the cervical region, soft tissue mobilization to the surrounding muscles, cervical manual traction, passive joint mobilization to the 7 cervical spine, passive joint mobilization to the 1st costa, passive joint mobilization to the clavicle and passive joint mobilization to the sternum mobilization in supine and prome positions.

Locations

Country	Name	City	State
Turkey	Denizli State Hospital	Denizli

Sponsors (1)

Lead Sponsor	Collaborator
Sule

Country where clinical trial is conducted

Turkey, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain Intensity	pain intensity at rest and activity will measure by VAS	Change from baseline pain intensity at 3 weeks
Secondary	Disability level	Disability level will measue by Neck Disability Index. Score ranges from 0-100. Higher score indicates worse outcome.	Change from baseline Neck Disability Index score at 3 weeks
Secondary	Depression level	Depression will measure by Beck Depression Inventory. Scores ranges from 0-63. Higher score indicates worse outcome.	Change from baseline Beck Depression Inventory score at 3 weeks