NCT04354194

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable chronic-pain

Timeline
Completed

Started Jul 2020

Shorter than P25 for not_applicable chronic-pain

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 13, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 21, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

July 1, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 20, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2020

Completed
Last Updated

June 4, 2020

Status Verified

June 1, 2020

Enrollment Period

3 months

First QC Date

April 13, 2020

Last Update Submit

June 2, 2020

Conditions

Keywords

Osteopathic Manipulative TreatmentChronic Non-spesific Neck PainConventional Therapy

Outcome Measures

Primary Outcomes (1)

  • Pain Intensity

    pain intensity at rest and activity will measure by VAS

    Change from baseline pain intensity at 3 weeks

Secondary Outcomes (2)

  • Disability level

    Change from baseline Neck Disability Index score at 3 weeks

  • Depression level

    Change from baseline Beck Depression Inventory score at 3 weeks

Study Arms (2)

Conventional Physiotherapy Group

EXPERIMENTAL

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

Procedure: Conventional Physiotherapy

Osteopathic Manipulative Treatment Group

EXPERIMENTAL

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

Procedure: Osteopathic Manupilative Treatment

Interventions

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.

Conventional Physiotherapy Group

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.

Osteopathic Manipulative Treatment Group

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Denizli State Hospital

Denizli, 20040, Turkey (Türkiye)

Location

Related Publications (4)

  • 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.

    PMID: 18617745BACKGROUND
  • 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.

    PMID: 10979164BACKGROUND
  • 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.

    PMID: 29780605BACKGROUND
  • 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.

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Nesrin Yağcı, Prof.

    Pamukkale University

    STUDY DIRECTOR

Central Study Contacts

Şule Şimşek, Phd

CONTACT

Merve Bergin Korkmaz, Dr.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 13, 2020

First Posted

April 21, 2020

Study Start

July 1, 2020

Primary Completion

September 20, 2020

Study Completion

December 20, 2020

Last Updated

June 4, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

Because there is no web site to share my data

Locations