NCT03622944

Brief Summary

The aim of the study is to determine the effect of exercise and two different manual therapy methods on pain, quality of life and posture in people with neck pain.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2015

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2015

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

July 18, 2018

Completed
22 days until next milestone

First Posted

Study publicly available on registry

August 9, 2018

Completed
Last Updated

August 9, 2018

Status Verified

August 1, 2018

Enrollment Period

5 months

First QC Date

July 18, 2018

Last Update Submit

August 8, 2018

Conditions

Keywords

neck painphysiotherapyrehabilitation

Outcome Measures

Primary Outcomes (1)

  • change in pain sensitivity

    pressure pain threshold (PPT) was measured with digital algometer. Pressure pain threshold which identifies minimum levels increasing mechanical stimulus is gold standard method for measuring pain sensitivity. PPT was measured from cervical vertebrae's spinous process and muscle belly's. Algometer range was set 0 kgF to 12kgF. Higher values represent increased pressure sensation.

    change from baseline PPT at six weeks

Secondary Outcomes (5)

  • change in Light touch sensation

    change from baseline light touch sensation at six weeks

  • change in upper extremity disability

    Change from baseline disability at six weeks .

  • change in posture

    change from baseline posture at six weeks

  • change in perceived life quality

    change from baseline life quality at six weeks

  • change in functional disability

    change from baseline functional disability at six weeks

Study Arms (3)

Muscle energy technic

ACTIVE COMPARATOR

post isometric relaxation technics were used as muscle energy technics.

Procedure: Muscle Energy TechnicProcedure: Exercise

Deep Friction Massage

ACTIVE COMPARATOR

Painful areas palpated and deep friction massage was applied.

Procedure: Deep Friction MassageProcedure: Exercise

exercise

ACTIVE COMPARATOR

Physiotherapist guided Spinal stabilization exercises were applied.

Procedure: Exercise

Interventions

post isometric relaxation technics were applied to levator scapulae, trapezius, pectoralis muscles three sessions per week, totally six weeks.

Muscle energy technic

deep friction massage was applied to cervical region included tendons, muscles and soft tissue.

Deep Friction Massage
ExercisePROCEDURE

spinal stabilization exercise were applied three sessions in a week totally six weeks.

Deep Friction MassageMuscle energy technicexercise

Eligibility Criteria

Age25 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • clinical diagnosis of cervical disorder (for example; chronic neck pain, cervical disc herniation)
  • must have pain at least three months.

You may not qualify if:

  • History of structural scoliosis
  • History of surgery
  • History of metabolic, neurologic and metastatic diseases.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • Rihn JA, Radcliff K, Hipp J, Vaccaro AR, Hilibrand AS, Anderson DG, Albert TJ. Radiographic variables that may predict clinical outcomes in cervical disk replacement surgery. J Spinal Disord Tech. 2015 Apr;28(3):106-13. doi: 10.1097/BSD.0b013e31826a0c84.

  • Carreon LY, Glassman SD, Campbell MJ, Anderson PA. Neck Disability Index, short form-36 physical component summary, and pain scales for neck and arm pain: the minimum clinically important difference and substantial clinical benefit after cervical spine fusion. Spine J. 2010 Jun;10(6):469-74. doi: 10.1016/j.spinee.2010.02.007. Epub 2010 Apr 1.

  • Persson LC, Lilja A. Pain, coping, emotional state and physical function in patients with chronic radicular neck pain. A comparison between patients treated with surgery, physiotherapy or neck collar--a blinded, prospective randomized study. Disabil Rehabil. 2001 May 20;23(8):325-35. doi: 10.1080/09638280010005567.

  • Boyles R, Toy P, Mellon J Jr, Hayes M, Hammer B. Effectiveness of manual physical therapy in the treatment of cervical radiculopathy: a systematic review. J Man Manip Ther. 2011 Aug;19(3):135-42. doi: 10.1179/2042618611Y.0000000011.

MeSH Terms

Conditions

Neck Pain

Interventions

Exercise

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Aynur Demirel, PhD

    Hacettepe University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 18, 2018

First Posted

August 9, 2018

Study Start

October 1, 2015

Primary Completion

March 1, 2016

Study Completion

October 1, 2016

Last Updated

August 9, 2018

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share