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

Primary Purpose

Cervicogenic Headache

Status
Completed
Phase
Not Applicable
Locations
Saudi Arabia
Study Type
Interventional
Intervention
Pressure biofeedback guided DCFM strength training
Manual therapy
Conventional intervention
Sponsored by
King Saud University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cervicogenic Headache focused on measuring Pressure biofeedback, Deep cervical flexor muscles, Muscle Strengthening, Manual therapy, Pain, Disability

Eligibility Criteria

25 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Rehabilitation Sciences, College of applied Medical Science, King Saud University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group 1

Group 2

Arm Description

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.

Thirty participants randomly allocated to group 2. All the participants received a manual therapy along wth conventional intervention.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
January 11, 2023
Last Updated
January 20, 2023
Sponsor
King Saud University
Collaborators
Majmaah University
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1. Study Identification

Unique Protocol Identification Number
NCT05692232
Brief Title
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

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
February 20, 2022 (Actual)
Primary Completion Date
August 19, 2022 (Actual)
Study Completion Date
September 29, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
King Saud University
Collaborators
Majmaah University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervicogenic Headache
Keywords
Pressure biofeedback, Deep cervical flexor muscles, Muscle Strengthening, Manual therapy, Pain, Disability

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Experimental
Arm Description
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.
Arm Title
Group 2
Arm Type
Active Comparator
Arm Description
Thirty participants randomly allocated to group 2. All the participants received a manual therapy along wth conventional intervention.
Intervention Type
Other
Intervention Name(s)
Pressure biofeedback guided DCFM strength training
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Manual therapy
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Conventional intervention
Intervention Description
A hot pads was applied for 20minutes underneath the cervical spine covering either side of shoulder in a relaxed supine position.
Primary Outcome Measure Information:
Title
Pain intensity
Description
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
Title
Functional limitations
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AMIR IQBAL, MPT
Organizational Affiliation
King Saud University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Rehabilitation Sciences, College of applied Medical Science, King Saud University
City
Riyadh
ZIP/Postal Code
11433
Country
Saudi Arabia

12. IPD Sharing Statement

Plan to Share IPD
No

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

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