Comparison of Different Manual Therapy Approaches in Patients With Chronic Neck Pain

March 3, 2023 updated by: seyda toprak celenay, Ankara Yildirim Beyazıt University
The aim of the study was to compare the effects of different manual therapy approaches on pain, cervical range of motion, balance, functional status and life quality in patients with chronic neck pain.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Various physiotherapy and rehabilitation methods are applied in the treatment of patients with chronic neck pain. Clinical practice guidelines for individuals with chronic neck pain recommend both manual therapy and exercise therapy among conservative treatments. Manual therapy are methods that can be safely applied to soft tissues and joints. Both manual therapy and exercise applications have been shown to have positive effects on neck pain and function. Some studies in the literature have also shown that manual therapy methods have positive effects on balance. However, no study examining the effects of different manual therapy (classical massage, connective tissue massage, manual joint techniques) approaches applied to individuals with chronic neck pain on pain, cervical range of motion, balance, functional status and quality of life was found in the literature.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • To be between the ages of 18-65.
  • To participate in the study voluntarily.
  • Having a complaint of neck pain for at least 3 months.

Exclusion Criteria:

  • To have undergone cervical spine surgery
  • Having cervical fracture and/or joint subluxation/dislocation
  • Severe degenerative arthritis
  • Having a neurological disease (Parkinson's disease, poliomyelitis, etc.) or an -inflammatory rheumatic disease (ankylosing spondylitis, rheumatoid arthritis, etc.)
  • Presence of malignancy
  • Having cord compression and signs
  • Severe radiculopathy or myelopathy
  • Positive vertebrobasilar artery test,
  • Pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Massage group
Massage group will be applied classic massage+cervical stabilisation exercises
Other: Massage group
Massage group will be applied classic massage and cervical stabilisation exercises 3 days a week for 4 weeks
Experimental: Connective tissue massage group
Connective tissue group will be applied connective tissue massage+cervical stabilisation exercises
Other: Connective tissue massage group
Connective tissue massage group will be applied connective tissue massage and cervical stabilisation exercises 3 days a week for 4 weeks
Experimental: Mobilization group
Mobilization group will be applied cervical mobilization techniques+cervical stabilisation exercises
Other: Mobilization group
Mobilization group will be applied cervical mobilization techniques and cervical stabilisation exercises 3 days a week for 4 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Intensity
Time Frame: change from baseline at 4 weeks
Pain intensity will be assessed with the Visual Analogue Scale (a 100 mm long horizontal line). Patient will be asked to score the pain he/she feels out of 10. The beginning of the figure is "0 "no pain", ending in "10 "there is unbearable pain".
change from baseline at 4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pressure Pain Threshold
Time Frame: change from baseline at 4 weeks
Pressure Pain Threshold will be assessed with a digital algometer device. The device that objectively measures the pain threshold will be used for the evaluation. The probe of the device will be pressed on the trapezius muscle. The first pain threshold felt will be recorded.
change from baseline at 4 weeks
Cervical Range of Motion
Time Frame: change from baseline at 4 weeks
Cervical range of motion will be evaluated with a goniometer in the sitting position. Neck flexion, extension, right-left lateral flexion and right-left rotation ranges of motion will be recorded
change from baseline at 4 weeks
Balance
Time Frame: change from baseline at 4 weeks
Balance will be evaluated with the Biodex Balance System Device. The individual is placed on a platform of the device that evaluates the ability to keep the centre of gravity on the support surface. Changes in the centre of gravity of the individual standing on this platform will be recorded with this device in static and dynamic, with eyes open and closed.
change from baseline at 4 weeks
Functional Status
Time Frame: change from baseline at 4 weeks
Functional Status will be assessed with Neck Disability Index. This index consists of 10 items. Each item was scored from 0 (no disability) to 5 (complete disability). The total score ranged from 0 (no disability) to 50 (total disability). As the score increased, disability increased and as the score decreased, disability decreased.
change from baseline at 4 weeks
Life quality
Time Frame: change from baseline at 4 weeks
Life quality will be assessed with Short Form-36 questionnaire. The questionnaire consists of 36 items. Scoring is done over 100 points and the scores are between 0 and 100 points for each sub-parameter. "0" is calculated as the worst value and "100" as the best value.
change from baseline at 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ankara Yildirim Beyazıt University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 30, 2023

Primary Completion (Anticipated)

April 30, 2023

Study Completion (Anticipated)

March 30, 2024

Study Registration Dates

First Submitted

March 3, 2023

First Submitted That Met QC Criteria

March 3, 2023

First Posted (Actual)

March 15, 2023

Study Record Updates

Last Update Posted (Actual)

March 15, 2023

Last Update Submitted That Met QC Criteria

March 3, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023/03/03

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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