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Osteopathic Manipulative Treatment in Chronic Non-specific Neck Pain

Primary Purpose

Chronic Pain

Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Conventional Physiotherapy
Osteopathic Manupilative Treatment
Sponsored by
Şule
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Pain focused on measuring Osteopathic Manipulative Treatment, Chronic Non-spesific Neck Pain, Conventional Therapy

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Denizli State Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Conventional Physiotherapy Group

Osteopathic Manipulative Treatment Group

Arm Description

This group will receive 15 sessions of conventional physiotherapy programme 5 times per week.

This group will receive 9 sessions of Osteopathic Manipulative Treatment programme 3 times per week.

Outcomes

Primary Outcome Measures

Pain Intensity
pain intensity at rest and activity will measure by VAS

Secondary Outcome Measures

Disability level
Disability level will measue by Neck Disability Index. Score ranges from 0-100. Higher score indicates worse outcome.
Depression level
Depression will measure by Beck Depression Inventory. Scores ranges from 0-63. Higher score indicates worse outcome.

Full Information

First Posted
April 13, 2020
Last Updated
June 2, 2020
Sponsor
Şule
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1. Study Identification

Unique Protocol Identification Number
NCT04354194
Brief Title
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

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2020 (Anticipated)
Primary Completion Date
September 20, 2020 (Anticipated)
Study Completion Date
December 20, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Şule

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain
Keywords
Osteopathic Manipulative Treatment, Chronic Non-spesific Neck Pain, Conventional Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Conventional Physiotherapy Group
Arm Type
Experimental
Arm Description
This group will receive 15 sessions of conventional physiotherapy programme 5 times per week.
Arm Title
Osteopathic Manipulative Treatment Group
Arm Type
Experimental
Arm Description
This group will receive 9 sessions of Osteopathic Manipulative Treatment programme 3 times per week.
Intervention Type
Procedure
Intervention Name(s)
Conventional Physiotherapy
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Osteopathic Manupilative Treatment
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pain Intensity
Description
pain intensity at rest and activity will measure by VAS
Time Frame
Change from baseline pain intensity at 3 weeks
Secondary Outcome Measure Information:
Title
Disability level
Description
Disability level will measue by Neck Disability Index. Score ranges from 0-100. Higher score indicates worse outcome.
Time Frame
Change from baseline Neck Disability Index score at 3 weeks
Title
Depression level
Description
Depression will measure by Beck Depression Inventory. Scores ranges from 0-63. Higher score indicates worse outcome.
Time Frame
Change from baseline Beck Depression Inventory score at 3 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Şule Şimşek, Phd
Phone
+905058099914
Email
sules@pau.edu.tr
First Name & Middle Initial & Last Name or Official Title & Degree
Merve Bergin Korkmaz, Dr.
Phone
+905469114635
Email
mbergina@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nesrin Yağcı, Prof.
Organizational Affiliation
Pamukkale University
Official's Role
Study Director
Facility Information:
Facility Name
Denizli State Hospital
City
Denizli
ZIP/Postal Code
20040
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Because there is no web site to share my data
Citations:
PubMed Identifier
18617745
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.
Results Reference
background
PubMed Identifier
10979164
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.
Results Reference
background
PubMed Identifier
29780605
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.
Results Reference
background
PubMed Identifier
30219451
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.
Results Reference
result

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Osteopathic Manipulative Treatment in Chronic Non-specific Neck Pain

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