Clinical trial NCT05692232: The Efficacy of Manual Therapy and Pressure Biofeedback Guided Strength Training on Pain and Functional Limitations
Official title: The Efficacy of Manual Therapy and Pressure Biofeedback Guided Deep Cervical Flexor Muscle Strength Training on Pain and Functional Limitations in Individuals With Cervicogenic Headaches. A Randomized Comparative Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cervicogenic Headache
Keywords: Pressure biofeedback
Deep cervical flexor muscles
Muscle Strengthening
Manual therapy
Pain
Disability
Lead sponsor: King Saud University
Sponsor class: OTHER
Collaborators: name: Majmaah University
First posted: 2023-01-20
Enrollment: 60
Sex: ALL
Minimum age (years): 25
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Cervicogenic headache (CGH) is a widespread illness that results in excruciating pain and a sizable functional handicap. Deep cervical flexor muscle (DCFM) strength and endurance were also worse in CGH patients. This study aimed to determine the efficacy of manual therapy and pressure biofeedback-guided DCFM strength training on pain intensity and functional limitations in individuals with CGH.

Detailed description: The study followed a two-arms parallel group randomized comparative design, including sixty individuals with CGH, and they were allocated into two groups at random. For three consecutive weeks, in addition to the conventional treatment common to both groups, groups 1 and 2 received pressure biofeedback-guided DCFM strength training and manual therapy, respectively. At baseline, the first week, the second week, and the third week post intervention, pain intensity and functional limitations were evaluated using the visual analog scale (VAS), the number of headache days per week, and the headache disability inventory (HDI) questionnaire. The main effects of the intervention were evaluated for a between-group factor, within-group factor, and interaction between time and groups over/at multiple time points. Data was analyzed using an independent t-test, mixed design 2-way ANOVA, with keeping the level of significance 'p' at 0.05.

Eligibility criteria: Inclusion Criteria:

* Individual with a diagnosed case of cervicogenic headache with unilateral head pain without side shift or bilateral head pain with a dominant side that hurts more than the other side, sustained awkward head positioning, external pressure over the upper cervical or occipital region on the symptomatic side.
* Aged between 25 and 50 years
* Patients with recurrent CGH and chronic mechanical neck discomfort that has persisted for longer than three months.
* A positive cervical flexion rotation test.

Exclusion Criteria:

* a negative cervical flexion rotation test.
* Subjects had a history of any of the following conditions: a fractured vertebral column or previous surgery on it; spinal stenosis; a prolapsed disc; temporomandibular joint dysfunction or headaches involving the autonomic nervous system; vertigo or visual disturbance; or a congenital condition of the cervical spine.
* Showed non-cooperation

Primary outcomes:
measure: Pain intensity
timeFrame: 6 weeks
measure: Functional limitations
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Riyadh
country: Saudi Arabia
facility: Department of Rehabilitation Sciences, College of applied Medical Science, King Saud University
Study officials:
affiliation: King Saud University
name: AMIR IQBAL, MPT
role: PRINCIPAL_INVESTIGATOR
References: