The Efficacy of Manual Therapy and Pressure Biofeedback Guided Strength Training on Pain and Functional Limitations

Not Applicable

Completed

• Conditions: Cervicogenic Headache
• Interventions: Other: Pressure biofeedback guided DCFM strength training; Other: Manual therapy; Other: Conventional intervention

• Registration Number: NCT05692232
• Lead Sponsor: King Saud University

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.

Study Timeline

• Study Start: 2022-02-20
• Primary Completion: 2022-08-19
• Study Completion: 2022-09-29
• Status Verified: 2023-01
• Study First Submitted: 2023-01-11
• Study First Submitted QC: 2023-01-11
• Study First Posted: 2023-01-20
• Last Update Submitted: 2023-01-20
• Last Update Posted: 2023-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1	Conventional intervention	Thirty participants randomly allocated to group 1. All the participants received a pressure biofeedback guided deep cervical flexor muscle strength training along wth conventional intervention.
Group 1	Pressure biofeedback guided DCFM strength training	Thirty participants randomly allocated to group 1. All the participants received a pressure biofeedback guided deep cervical flexor muscle strength training along wth conventional intervention.
Group 2	Manual therapy	Thirty participants randomly allocated to group 2. All the participants received a manual therapy along wth conventional intervention.
Group 2	Conventional intervention	Thirty participants randomly allocated to group 2. All the participants received a manual therapy along wth conventional intervention.

Primary Outcome Measures

Name	Time	Method
Pain intensity	6 weeks	The pain intensity was assessed by a visual analogue scale. It is a reliable and valid tool to measure the pain intensity. It is an objective line marked with zero indicate no pain and ten indicate maximum unbearable pain at the either end of the line. Individuals are asked to show the level of pain by putting their fingers on the line between either ends.
Functional limitations	6 weeks	The functional limitation due to cervicogenic headache was evaluated by a self-rated questionnaire called as, Headache Disability Index. A minimum and maximum scores ranges from 0 to 100. a score of 10-28 is considered to constitute mild disability; 30-48 is moderate disability; 50-68 is severe disability; 72 or more is complete disability.

Trial Locations

Locations (1)

Department of Rehabilitation Sciences, College of applied Medical Science, King Saud University; 🇸🇦 Riyadh, Saudi Arabia