An interventional study of Pressure biofeedback guided DCFM strength training and Manual therapy in Cervicogenic Headache, sponsored by King Saud University. Completed at 1 site in Saudi Arabia. Open to participants aged 25 Years to 50 Years. Per ClinicalTrials.gov, last updated 2023-01-25.
Sponsored by King Saud University · Not applicable, Interventional, and Treatment
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.
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.
188 studies on the registry are indexed under Post-Traumatic Headache; 50 are open to participants now.
This study's enrollment of 60 is above the median of 44 across 166 interventional studies indexed under Post-Traumatic Headache.
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Exclusion Criteria:
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.
Other: Pressure biofeedback guided DCFM strength training · Other: Conventional intervention
Thirty participants randomly allocated to group 2. All the participants received a manual therapy along wth conventional intervention.
Other: Manual therapy · Other: Conventional intervention
A pressure biofeedback guided DCFM strength training was carried out according to the Jull protocol. Keeping the participant's cervical spine in a neutral position and ensuring a stabilizer pressure biofeedback unit placed beneath the cervical lordosis. The pressure sensor was inflated at 20mm Hg. The participants were asked to nod their heads slowly. As the DCFM is activated, the cervical lordosis gently flattens, and the pressure sensor measures an increase in pressure. The activation score is the maximum pressure that can maintain for 10 seconds.
A manual therapy, including a slow, sustained elongation of muscles with a holding period of 7-10 seconds and a superficial oscillatory mobilization (grade-I) with 1-2 oscillations per second for 30 seconds per session was performed on the DCFM and at the cervical spine (C0-C5), respectively. The participants were asked to lie supine and prone while delivering stretching and mobilization, respectively.
A hot pads was applied for 20minutes underneath the cervical spine covering either side of shoulder in a relaxed supine position.
Pain intensity
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.
Time frame: 6 weeks
Functional limitations
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.
Time frame: 6 weeks
Plan to share: No
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This study is completed, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.
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King Saud University