Osteopathic Manipulative Treatment in Chronic Non-specific Neck Pain

NCT ID: NCT04354194

Last Updated: 2020-06-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-01

Study Completion Date

2020-12-20

Brief Summary

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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

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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.

Conditions

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Chronic Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Conventional Physiotherapy Group

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

Group Type EXPERIMENTAL

Conventional Physiotherapy

Intervention Type PROCEDURE

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 Manipulative Treatment Group

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

Group Type EXPERIMENTAL

Osteopathic Manupilative Treatment

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type PROCEDURE

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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Şule

OTHER

Sponsor Role lead

Responsible Party

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Şule

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Nesrin Yağcı, Prof.

Role: STUDY_DIRECTOR

Pamukkale University

Locations

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Denizli State Hospital

Denizli, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Central Contacts

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Şule Şimşek, Phd

Role: CONTACT

+905058099914

Merve Bergin Korkmaz, Dr.

Role: CONTACT

+905469114635

References

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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.

Reference Type BACKGROUND
PMID: 18617745 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10979164 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29780605 (View on PubMed)

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.

Reference Type RESULT
PMID: 30219451 (View on PubMed)

Other Identifiers

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21.05.2019/10

Identifier Type: -

Identifier Source: org_study_id

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