NCT07494734

Brief Summary

The aim of this study is to investigate whether conventional physical therapy combined with manual therapy reduces pain and maintains life support in individuals with chronic mechanical neck pain, compared to conventional physical therapy alone. The study plans to evaluate the combined benefits of both treatment methods and manual therapy. Pain, quality of life, range of motion, and neck injuries will be assessed in the participants. The treatment protocol will be administered twice a week, for a total of 10 sessions over a 5-week period.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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

Study Start

First participant enrolled

March 15, 2026

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

March 20, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 27, 2026

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 10, 2026

Completed
Last Updated

March 27, 2026

Status Verified

March 1, 2026

Enrollment Period

2 months

First QC Date

March 20, 2026

Last Update Submit

March 20, 2026

Conditions

Keywords

Manual therapyQuality of lifeDisabilityNeck pain

Outcome Measures

Primary Outcomes (4)

  • Pain Assessment

    Visual Pain Scale

    Baseline and at the end of treatment (week 5)

  • Range of motion

    The data will be recorded in the range of motion assessment section of the patient evaluation form. While the participant is in a seated position, the measurement results of active flexion, extension, right and left rotation, right and left lateral flexion movements of the cervical region will be recorded.

    Baseline and at the end of treatment (week 5)

  • Disability

    Bournemoth Neck :The BDI consists of 10 categories: neck pain intensity, personal care, lifting, reading, headache, concentration, work, driving, sleep, and leisure activities. Individuals included in the study were asked to rate each category between 0 (no disability) and 5 (complete disability) (Vernon, 2008). The total score ranged from 0 (no disability) to 50 (complete disability).

    Baseline and at the end of treatment (week 5)

  • quality of life

    The SF-36 Quality of Life Scale consists of 36 items assessed across 8 separate subscales. Physical function, social function, general health, fitness, mental health, pain, and physical and emotional role limitations are the subscales of the SF-36. Each subscale can be scored between 0 and 100.

    Baseline and at the end of treatment (week 5)

Study Arms (2)

Physical Therapy

OTHER

Conventional physical therapy includes transcutaneous electrical nerve stimulation (TENS), infrared device application, and exercise programs.

Other: Physical therapy

Physical therapy and Manual therapy

EXPERIMENTAL

Cervical region mobilization techniques include bridging, cervical manual traction, rotation with traction, lateral flexion with traction, antero-posterior sliding and lateral sliding techniques with traction. Prior to joint mobilization techniques, bilaterally, soft tissue techniques including myofascial release techniques and ischemic compression will be applied to the cervical paravertebral muscles, upper and middle trapezius, levator scapula, sternocleidomastoid (SCM), anterior-medius posterior scalene muscles, deep and superficial fascia to reduce muscle spasm in the soft tissues and relax the cervical muscles. Transverse friction massage will be applied to the occipital attachment points of the semispinalis capitis and splenius capitis muscles.

Other: Physical therapy and manual therapy

Interventions

Traditional physiotherapy includes transcutaneous electrical nerve stimulation (TENS), infrared device application, and exercise programs.

Physical Therapy

Cervical region mobilization techniques include bridging, cervical manual traction, rotation with traction, lateral flexion with traction, antero-posterior sliding and lateral sliding techniques with traction. Prior to joint mobilization techniques, bilaterally, soft tissue techniques including myofascial release techniques and ischemic compression will be applied to the cervical paravertebral muscles, upper and middle trapezius, levator scapula, sternocleidomastoid (SCM), anterior-medius posterior scalene muscles, deep and superficial fascia to reduce muscle spasm in the soft tissues and relax the cervical muscles. Transverse friction massage will be applied to the occipital attachment points of the semispinalis capitis and splenius capitis muscles.

Physical therapy and Manual therapy

Eligibility Criteria

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

You may qualify if:

  • Being between 18-65 years of age
  • Having neck pain that has lasted for at least three months
  • Having a Visual Analog Scale (VAS) score of at least 3

You may not qualify if:

  • Patients not aged 18-60 years
  • Pregnant women or those suspected of being pregnant
  • Individuals with acute inflammatory diseases
  • Individuals with neurological deficits
  • Individuals with a positive vertebrobasilar artery test
  • Individuals with advanced osteoporosis
  • Individuals who have undergone spinal surgery
  • Individuals who have received an injection in the cervical region within the last 3 months
  • Individuals with any neurological or psychiatric disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Physiotherapy center

Kocaeli, Gebze, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Neck Pain

Interventions

Physical Therapy ModalitiesMusculoskeletal Manipulations

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

TherapeuticsRehabilitationComplementary Therapies

Study Design

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

Study Record Dates

First Submitted

March 20, 2026

First Posted

March 27, 2026

Study Start

March 15, 2026

Primary Completion

May 1, 2026

Study Completion

May 10, 2026

Last Updated

March 27, 2026

Record last verified: 2026-03

Locations