NCT07605013

Brief Summary

This clinical study investigates the comparative effects of two manual therapy mobilization techniques, Positional Release Technique (PRT) and Instrument-Assisted Soft Tissue Mobilization (İASTM), on cervical muscle endurance and functional performance in individuals with nonspecific neck pain. Nonspecific neck pain is a common musculoskeletal condition among office workers and students, often associated with poor posture, prolonged sitting, and repetitive strain. It leads to reduced muscle endurance, impaired functional capacity, and decreased quality of life. Early and effective management strategies are essential to prevent chronicity and disability. A total of 51 participants will be recruited and randomly assigned into three groups: Group 1 will receive PRT combined with a standardized home exercise program, Group 2 will receive İASTM combined with the same home exercise program, and Group 3 will serve as the control group receiving only conventional home exercise. The interventions will be delivered over a period of 4 weeks, with three sessions per week, under the supervision of trained physiotherapists. The home exercise program includes stretching, strengthening, and posture correction exercises designed to support cervical spine health. The primary outcomes of the study are cervical muscle endurance and functional performance, measured using validated clinical tests. Secondary outcomes include pain intensity assessed by the Visual Analog Scale (VAS), functional disability measured by the Neck Disability Index (NDI), health-related quality of life assessed by the SF-12 questionnaire, and work-related performance indicators. Assessments will be conducted at baseline and after 4 weeks of intervention. Randomization and blinding procedures will be applied to minimize bias, and standardized protocols will ensure consistency across groups. The main objective of this study is to determine whether the early application of PRT or İASTM, in combination with home exercise, provides superior improvements in cervical muscle endurance, pain reduction, and functional outcomes compared to exercise alone. By comparing these two mobilization techniques, the study aims to contribute evidence-based knowledge to physiotherapy practice and guide clinicians in selecting effective manual therapy approaches for nonspecific neck pain. The findings are expected to support clinical decision-making, improve patient care, and enhance rehabilitation strategies for individuals suffering from neck pain in occupational and daily life contexts.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
51

participants targeted

Target at P25-P50 for not_applicable

Timeline
8mo left

Started Mar 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress22%
Mar 2026Jan 2027

Study Start

First participant enrolled

March 16, 2026

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 17, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 22, 2026

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 16, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 16, 2027

Last Updated

May 22, 2026

Status Verified

May 1, 2026

Enrollment Period

10 months

First QC Date

May 17, 2026

Last Update Submit

May 17, 2026

Conditions

Keywords

Nonspecific Neck PainManual TherapyPositional Release TechniqueInstrument-Assisted Soft Tissue MobilizationCervical Muscle EndurancePhysiotherapyRandomized Controlled TrialOffice Workers

Outcome Measures

Primary Outcomes (1)

  • Neck Disability Index (NDI)

    Description Change in Neck Disability Index (NDI) score from baseline to post-intervention (4 weeks). The NDI is a validated questionnaire assessing neck-related functional disability. Higher scores indicate greater disability.

    Baseline and 4 weeks after intervention.

Study Arms (3)

Positional Release Technique Group (PRT Group)

EXPERIMENTAL

Participants receive Positional Release Technique sessions three times per week for four weeks (12 sessions total, 45-60 minutes each). The intervention focuses on upper trapezius and sternocleidomastoid trigger points, combined with home exercises including stretching, chin tuck endurance, and scapular stabilization.

Procedure: Positional Release Technique (PRT)

Instrument-Assisted Soft Tissue Mobilization Group (İASTM Group)

EXPERIMENTAL

Participants receive Instrument-Assisted Soft Tissue Mobilization three times per week for four weeks (12 sessions total, 45-60 minutes each). Stainless steel tools are used at 30-60° angles along muscle fibers. Home exercises include stretching, chin tuck endurance, and scapular stabilization.

Procedure: Instrument-Assisted Soft Tissue Mobilization (İASTM)

Control Group (Exercise Only)

ACTIVE COMPARATOR

Participants perform only home exercise programs three times per week for four weeks (45-60 minutes each). Exercises include stretching, chin tuck endurance, and scapular stabilization.

Behavioral: Control Group

Interventions

The Positional Release Technique involves passive positioning of the cervical spine to relieve muscle tension at trigger points. Each position is held for 90 seconds and repeated three times per session. Participants receive 12 sessions over 4 weeks (3 sessions per week, 45-60 minutes each).

Positional Release Technique Group (PRT Group)

Instrument-Assisted Soft Tissue Mobilization uses stainless steel tools applied at 30-60° angles along muscle fibers to reduce soft tissue restrictions. Each area is treated for 60-90 seconds, with total manual contact lasting 8-12 minutes per session. Participants receive 12 sessions over 4 weeks (3 sessions per week, 45-60 minutes each).

Instrument-Assisted Soft Tissue Mobilization Group (İASTM Group)
Control GroupBEHAVIORAL

Participants perform only home exercise programs three times per week for four weeks (45-60 minutes each session). Exercises include static stretching of the upper trapezius, levator scapula, and scalene muscles (30 seconds × 3 sets), chin tuck endurance exercise (10 seconds × 10 repetitions), and scapular stabilization strengthening (3 sets × 10-15 repetitions). Exercises are guided by video instructions and mobile reminders.

Control Group (Exercise Only)

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy individuals aged 18-40 years Individuals working at a desk job (office or remote) for at least 6 hours per day Physically active individuals with no neck pain (NPRS score 0-2) Voluntary consent to participate in the study

You may not qualify if:

  • History of neck trauma, surgery, or any cardiovascular, metabolic, neurological, or rheumatoid arthritis condition within the last 6 months Participation in a manual therapy or physiotherapy program within the last 6 months Presence of severe malignancy, rheumatoid arthritis, or cardiovascular disease Pregnancy or breastfeeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul University-Cerrahpasa, Faculty of Health Sciences, Department of Physical Therapy and Rehabilitation, Healthy Living Laboratory

Istanbul, 34098, Turkey (Türkiye)

RECRUITING

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • GUNEY SHIRVANOVA, BSc PT

    Istanbul University-Cerrahpasa, Department of Physical Therapy and Rehabilitation

    PRINCIPAL INVESTIGATOR

Central Study Contacts

GUNEY SHIRVANOVA, BSc PT

CONTACT

YILDIZ ANALAY AKBABA, Prof.Dr

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
In this trial, only the outcomes assessor is blinded to group allocation. Participants, care providers, and investigators are aware of the assigned interventions. The assessor conducting outcome measurements does not know which intervention each participant received.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants will be randomly assigned to three parallel groups: Group 1 will receive Positional Release Technique combined with home exercise, Group 2 will receive Instrument-Assisted Soft Tissue Mobilization combined with home exercise, and Group 3 will perform only the standardized home exercise program. All groups will be followed simultaneously for 4 weeks.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 17, 2026

First Posted

May 22, 2026

Study Start

March 16, 2026

Primary Completion (Estimated)

January 16, 2027

Study Completion (Estimated)

January 16, 2027

Last Updated

May 22, 2026

Record last verified: 2026-05

Locations