NCT05769179

Brief Summary

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.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2023

Status
unknown

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

First Submitted

Initial submission to the registry

March 3, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 15, 2023

Completed
15 days until next milestone

Study Start

First participant enrolled

March 30, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2023

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2024

Completed
Last Updated

March 15, 2023

Status Verified

March 1, 2023

Enrollment Period

1 month

First QC Date

March 3, 2023

Last Update Submit

March 3, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Pain Intensity

    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 Outcomes (5)

  • Pressure Pain Threshold

    change from baseline at 4 weeks

  • Cervical Range of Motion

    change from baseline at 4 weeks

  • Balance

    change from baseline at 4 weeks

  • Functional Status

    change from baseline at 4 weeks

  • Life quality

    change from baseline at 4 weeks

Study Arms (3)

Massage group

EXPERIMENTAL

Massage group will be applied classic massage+cervical stabilisation exercises

Other: Massage group

Connective tissue massage group

EXPERIMENTAL

Connective tissue group will be applied connective tissue massage+cervical stabilisation exercises

Other: Connective tissue massage group

Mobilization group

EXPERIMENTAL

Mobilization group will be applied cervical mobilization techniques+cervical stabilisation exercises

Other: Mobilization group

Interventions

Massage group will be applied classic massage and cervical stabilisation exercises 3 days a week for 4 weeks

Massage group

Connective tissue massage group will be applied connective tissue massage and cervical stabilisation exercises 3 days a week for 4 weeks

Connective tissue massage group

Mobilization group will be applied cervical mobilization techniques and cervical stabilisation exercises 3 days a week for 4 weeks

Mobilization group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Neck Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Seyda Toprak Celenay

    Ankara Yildirim Beyazıt University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Seyda Toprak Celenay

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate professor

Study Record Dates

First Submitted

March 3, 2023

First Posted

March 15, 2023

Study Start

March 30, 2023

Primary Completion

April 30, 2023

Study Completion

March 30, 2024

Last Updated

March 15, 2023

Record last verified: 2023-03