NCT07575542

Brief Summary

This prospective, single-blind, parallel-group randomized controlled trial evaluated whether adding cervical and thoracic spinal mobilization (Maitland concept, grades I-IV) to a structured home therapeutic exercise program improves pain intensity and physical fitness parameters in recreational tennis players with mechanical neck pain. Thirty adults aged 18-45 years with body mass index (BMI) of 18-30 kg/m² and mechanical neck pain (Visual Analog Scale, VAS \> 4) lasting more than one week were randomized 1:1 into a Control Group (CG, n=15) performing an unsupervised 21-session home exercise program (one session per day for three weeks) and an Experimental Group (EG, n=15) performing the identical home exercise program plus four therapist-delivered sessions of cervical and upper thoracic spinal mobilization (one at baseline and one per week thereafter, across three weeks). Outcomes assessed at baseline (Week 0) and post-intervention (Week 3) included VAS for pain during physical activity, at rest, and during sleep; cervical range of motion measured with a Cervical Range of Motion (CROM) device; isometric neck muscle strength (handheld dynamometer); pinch and hand grip strength; ruler-drop reaction time; sit-and-reach flexibility; and vertical jump performance assessed with the My Jump Lab application.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

April 1, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2025

Completed
17 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2025

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

May 3, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 8, 2026

Completed
Last Updated

May 8, 2026

Status Verified

May 1, 2026

Enrollment Period

4 months

First QC Date

May 3, 2026

Last Update Submit

May 3, 2026

Conditions

Keywords

Mechanical neck painTennispainManual therapytherapeutic exercise

Outcome Measures

Primary Outcomes (1)

  • Pain intensity - Visual Analog Scale (VAS) during physical activity (0-10 cm)

    Self-reported pain intensity rated by the participant on a 10 cm horizontal Visual Analog Scale anchored from "no pain" (0) to "worst imaginable pain" (10), scored to one decimal in centimeters; lower scores indicate less pain. Safety Issue: No.

    Baseline (Week 0) and Post-Intervention (Week 3)

Secondary Outcomes (8)

  • Pain intensity - Visual Analog Scale (VAS) at rest and during sleep (0-10 cm)

    Baseline (Week 0) and Post-Intervention (Week 3)

  • Cervical Range of Motion (CROM) - degrees

    Baseline (Week 0) and Post-Intervention (Week 3)

  • Isometric Neck Muscle Strength - kilograms-force (kgf)

    Baseline (Week 0) and Post-Intervention (Week 3)

  • Hand Grip Strength - kilograms (kg)

    Baseline (Week 0) and Post-Intervention (Week 3)

  • Pinch Grip Strength - kilograms (kg)

    Time Frame: Baseline (Week 0) and Post-Intervention (Week 3)

  • +3 more secondary outcomes

Study Arms (2)

Active Comparator: Control Group (CG)

ACTIVE COMPARATOR

Control Group (CG, n=15): Participants performed an unsupervised structured home therapeutic exercise program for three weeks (one session per day; 21 sessions total). The program comprised bilateral stretching of the upper trapezius and levator scapulae muscles, hamstring and lumbar extensor stretching, isometric resistance exercises for cervical flexion, extension, and bilateral lateral flexion, the chin-tuck exercise, and the cat-camel exercise. Written instructions with illustrations were provided

Behavioral: Behavioral: Home Therapeutic Exercise Program

Experimental: Experimental Group (EG)

EXPERIMENTAL

Experimental Group (EG, n=15): Participants performed the identical home therapeutic exercise program as the Control Group AND received four supervised sessions of Maitland-concept spinal mobilization (cervical and upper thoracic) delivered by a physiotherapist (one session at baseline and one session per week thereafter, total of four sessions across three weeks). Mobilizations used grades I-IV depending on the relationship between pain and motion limit, with oscillations at 2-3 Hz, \~30 seconds per bout, 3-4 bouts per segment, and 1-minute rest between bouts.

Behavioral: Behavioral: Home Therapeutic Exercise ProgramProcedure: Maitland Cervical and Upper Thoracic Spinal Mobilization

Interventions

Three weeks (21 daily sessions) of unsupervised home exercises supported by written and illustrated instructions. Components included bilateral upper trapezius and levator scapulae stretching, hamstring and lumbar extensor stretching, isometric cervical flexion / extension / bilateral lateral flexion exercises, chin-tuck exercise, and cat-camel exercise.

Active Comparator: Control Group (CG)Experimental: Experimental Group (EG)

Therapist-delivered passive oscillatory mobilization to hypomobile cervical and upper thoracic segments using grades I-IV per the Maitland concept; oscillation rate 2-3 Hz; \~30-second bouts; 3-4 bouts per segment; 1-minute rest between bouts. Total of four supervised sessions (one at baseline, then once per week) across three weeks.

Experimental: Experimental Group (EG)

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age between 18 and 45 years.
  • Body Mass Index (BMI) between 18 and 30 kg/m².
  • Recreational tennis player, playing tennis at least 2 days per week and at least 2 hours per week.
  • Mechanical neck pain triggered by neck movement or sustained positions on the symptomatic side.
  • Reduced cervical range of motion as confirmed by a positive cervical flexion-rotation test.
  • Pain elicited by external pressure over at least one cervical zygapophyseal (facet) joint.
  • Neck pain of at least 1 week duration, with intensity greater than 4/10 on the Visual Analog Scale (VAS), not associated with any specific medical history.
  • Able to communicate in Turkish or English (verbal and written).
  • Free from systemic, orthopedic, neurological, chronic, or psychiatric disease.

You may not qualify if:

  • Neck pain of more than 6 months duration.
  • Concomitant sensory loss (paresthesia, hypoesthesia, or anesthesia).
  • Pain radiating to the upper extremities (radicular symptoms).
  • History of long-term systemic corticosteroid use.
  • Regular use of medications affecting musculoskeletal performance or pain perception.
  • Sequelae from prior injury or any surgical history involving the cervical or thoracic spine.
  • Prior interventional procedures targeting the neck region (e.g., injection therapy).
  • Pregnancy or suspected pregnancy.
  • During the study: pain greater than 3/10 on VAS during sessions, three consecutive missed sessions, incident illness or trauma, withdrawal request, or failure to meet exercise progression criteria.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istinye University

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Single (Outcomes Assessor). The outcome assessor performing baseline and post-intervention measurements was blinded to group allocation; participants and the treating physiotherapist were not blinded due to the nature of the manual therapy intervention
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Parallel Assignment - Two-arm, single-blind randomized controlled superiority trial.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor; PhD

Study Record Dates

First Submitted

May 3, 2026

First Posted

May 8, 2026

Study Start

April 1, 2025

Primary Completion

July 15, 2025

Study Completion

August 1, 2025

Last Updated

May 8, 2026

Record last verified: 2026-05

Locations