Clinical trial NCT06926738: Effect of Upper Thoracic Manipulation on Neck Pain and Selected Muscle Activities
Official title: Effect of Upper Thoracic Spine Manipulation on Cervical Symptoms and Selected Muscle Activities in Chronic Mechanical Neck Pain
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Neck Pain
Keywords: Neck Pain
Thoracic manipulation
Manual Therapy
Neck pain with Mobility Deficits
Muscle activity
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2025-04-15
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. 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).
2. Age between 18-40 (J. Dunning \& Rushton, 2009)
3. Negative four tests of the Wainner cluster to exclude NP with radiating pain (Wainner et al., 2003).
4. Hypomobility of at least one of the upper thoracic vertebrae (T1-T4) during segmental mobility assessment (Ssavedra-Hernández et al., 2011).

Exclusion Criteria:

1. Subjects diagnosed as cervical radiculopathy or myelopathy (Ssavedra-Hernández et al., 2011).
2. 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).
3. The presence of contraindications of spinal manipulation as spinal infection and spinal osteoporosis(Ssavedra-Hernández et al., 2011).

Primary outcomes:
measure: Pain intensity
timeFrame: Pre-intervention, Immediately Post-Intervention, One-week Post-intervention, Two-week post-intervention.
Secondary outcomes:
measure: Cervical Range of Motion
timeFrame: Pre-intervention, Immediately Post-Intervention, One-week Post-intervention, Two-week post-intervention.
measure: Sternocleidomastoid muscle activity
timeFrame: Pre-intervention, Immediately Post-Intervention, One-week Post-intervention, Two-week post-intervention.
measure: Upper trapezius muscle activity
timeFrame: Pre-intervention, Immediately Post-Intervention, One-week Post-intervention, Two-week post-intervention.
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: CairoU
city: Giza
country: Egypt
facility: Faculty of Physical Therapy, Cairo University
Study officials:
References: