NCT06926738

Brief Summary

This study will investigate the immediate and short-term effects of upper thoracic manipulation versus sham upper thoracic manipulation on Pain intensity, Cervical ROM, the myoelectric activity of the sternocleidomastoid muscle and upper trapezius muscle during Maximum voluntary isometric contraction.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

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

First Submitted

Initial submission to the registry

April 5, 2025

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 15, 2025

Completed
Same day until next milestone

Study Start

First participant enrolled

April 15, 2025

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2026

Completed
Last Updated

March 3, 2026

Status Verified

January 1, 2025

Enrollment Period

10 months

First QC Date

April 5, 2025

Last Update Submit

February 28, 2026

Conditions

Keywords

Neck PainThoracic manipulationManual TherapyNeck pain with Mobility DeficitsMuscle activity

Outcome Measures

Primary Outcomes (1)

  • Pain intensity

    A hard copy of the Visual analogue scale will be given to the patient who will be asked to mark a perpendicular line between the two borders of the scale to express his/her pain level. It will be measured pre-treatment, post-treatment, and each week for 2 weeks. The level of pain will be measured at the end range of active extension.

    Pre-intervention, Immediately Post-Intervention, One-week Post-intervention, Two-week post-intervention.

Secondary Outcomes (3)

  • Cervical Range of Motion

    Pre-intervention, Immediately Post-Intervention, One-week Post-intervention, Two-week post-intervention.

  • Sternocleidomastoid muscle activity

    Pre-intervention, Immediately Post-Intervention, One-week Post-intervention, Two-week post-intervention.

  • Upper trapezius muscle activity

    Pre-intervention, Immediately Post-Intervention, One-week Post-intervention, Two-week post-intervention.

Study Arms (2)

Upper thoracic manipulation group

EXPERIMENTAL

The Patients in this group will receive Upper Thoracic Manipulation.

Other: Upper Thoracic Manipulation

Sham Upper Thoracic Manipulation

SHAM COMPARATOR

The patients in this group will receive the sham upper thoracic manipulation.

Other: Sham Comparison

Interventions

Segmental mobility will be assessed using posteroanterior central vertebral pressure and posteroanterior unilateral vertebral pressure. It will be done while the patient lies in a prone position and the examiner stands at the level of the patient's head. Afterwards, the subjects in the thoracic manipulation group will be asked to lie in a prone position on a standard examination table and they were marked on both sides of the zygapophyseal joint of the selected segments including levels from T1- T4. Subjects will then be instructed to perform deep inhalation and exhalation and at the end of exhalation, the Clinician will perform thoracic manipulation (screw thrust technique) at the selected segmental level/s. This maneuver will be repeated for a maximum of two attempts in case of no hearing of a pop sound. It will be performed by an experienced physiotherapist with more than 10-year experience.

Upper thoracic manipulation group

Segmental mobility will be assessed using posteroanterior central vertebral pressure and posteroanterior unilateral vertebral pressure. It will be done while the patient lies in a prone position and the examiner stands at the level of the patient's head. Afterwards, the subjects in the thoracic manipulation group will be asked to lie in a prone position on a standard examination table and they were marked on both sides of the zygapophyseal joint of the selected segments including levels from T1- T4. Subjects will then be instructed to perform deep inhalation and exhalation and at the end of exhalation, the Clinician will just the place the hands on the selected levels in the same hand placement of Thoracic manipulation group (screw thrust technique) without applying the manipulation. It will be performed by an experienced physiotherapist with more than 10-year experience.

Sham Upper Thoracic Manipulation

Eligibility Criteria

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

You may qualify if:

  • Male and female subjects diagnosed and classified as having chronic non-specific NP with mobility disorders based on clinical guidelines of NP:
  • Having NP for at least 3 months that may be associated with referred shoulder or upper extremity pain (Blanpied et al., 2017; Erdem et al., 2021; Puntumetakul et al., 2015).
  • Present with a limitation of cervical ROM and their pain can be provoked by sustained end-range spinal movements or positions will be included (Blanpied et al., 2017).
  • Patients present with unilateral or bilateral symptoms will be included (Blanpied et al., 2017; Yang et al., 2015).
  • Age between 18-40 (J. Dunning \& Rushton, 2009)
  • Negative four tests of the Wainner cluster to exclude NP with radiating pain (Wainner et al., 2003).
  • Hypomobility of at least one of the upper thoracic vertebrae (T1-T4) during segmental mobility assessment (Ssavedra-Hernández et al., 2011).

You may not qualify if:

  • Subjects diagnosed as cervical radiculopathy or myelopathy (Ssavedra-Hernández et al., 2011).
  • A history of whiplash injury, past cervical or thoracic surgery, rheumatoid arthritis, spinal fracture, heart disease, a recent significant trauma, and meningitis (Joshi et al., 2020; Puntumetakul et al., 2015).
  • The presence of contraindications of spinal manipulation as spinal infection and spinal osteoporosis(Ssavedra-Hernández et al., 2011).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

CairoU

Giza, 12611, Egypt

Location

Faculty of Physical Therapy, Cairo University

Giza, 12611, Egypt

Location

MeSH Terms

Conditions

Neck Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant lecturer

Study Record Dates

First Submitted

April 5, 2025

First Posted

April 15, 2025

Study Start

April 15, 2025

Primary Completion

February 1, 2026

Study Completion

February 1, 2026

Last Updated

March 3, 2026

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations