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Clinical Trials/NCT06926738
NCT06926738CompletedNot Applicable

Effect of Upper Thoracic Spine Manipulation on Cervical Symptoms and Selected Muscle Activities in Chronic Mechanical Neck Pain

Cairo University2 sites in 1 country42 target enrollmentStarted: April 15, 2025Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
42
Locations
2
Primary Endpoint
Pain intensity

Study Overview

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.

Detailed Description

This study will investigate the immediate and short-term effects of upper thoracic manipulation versus sham upper thoracic manipulation on Pain intensity measured by the visual analogue scale, Cervical ROM measured by CROM, the myoelectric activity of the sternocleidomastoid muscle and upper trapezius muscle during Maximum voluntary isometric contraction measured by Neuro-Soft using surface electrodes. All outcomes will be measured Pre-intervention, Immediately Post-Intervention, One-week Post-intervention, Two-week post-intervention.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Participant)

Eligibility Criteria

Ages
18 Years to 40 Years (Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •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).

Exclusion Criteria

  • •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).

Arms & Interventions

Upper thoracic manipulation group

Experimental

The Patients in this group will receive Upper Thoracic Manipulation.

Intervention: Upper Thoracic Manipulation (Other)

Sham Upper Thoracic Manipulation

Sham Comparator

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

Intervention: Sham Comparison (Other)

Outcomes

Primary Outcomes

Pain intensity

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

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.

Secondary Outcomes

  • 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.)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Mohamed Nagy Hassan Abdelhamid

Assistant lecturer

Cairo University

Study Sites (2)

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