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

NCT05692232 | Completed

• 1 other identifier: RRC-2022-04
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Cervicogenic Headache

Keywords

Pressure biofeedback; Deep cervical flexor muscles; Muscle Strengthening; Manual therapy; Pain; Disability

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  6 weeks

Study Arms (2)

Group 1

EXPERIMENTAL

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

Group 2

ACTIVE COMPARATOR

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

Other: Manual therapy; Other: Conventional intervention

Interventions

Pressure biofeedback guided DCFM strength training OTHER

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.

Group 1

Manual therapy OTHER

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.

Group 2

Conventional intervention OTHER

A hot pads was applied for 20minutes underneath the cervical spine covering either side of shoulder in a relaxed supine position.

Group 1; Group 2

Eligibility Criteria

• Age: 25 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• King Saud University: lead
• Majmaah University: collaborator

Study Sites (1)

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

Riyadh, 11433, Saudi Arabia

Location

Related Publications (1)

• Hasan S, Bharti N, Alghadir AH, Iqbal A, Shahzad N, Ibrahim AR. 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. Pain Res Manag. 2023 Aug 14;2023:1799005. doi: 10.1155/2023/1799005. eCollection 2023.

  PMID: 37608909 DERIVED

MeSH Terms

Conditions

Post-Traumatic Headache; Pain

Interventions

Musculoskeletal Manipulations

Condition Hierarchy (Ancestors)

Headache Disorders, Secondary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• AMIR IQBAL, MPT

  King Saud University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher

Study Record Dates

• First Submitted: January 11, 2023
• First Posted: January 20, 2023
• Study Start: February 20, 2022
• Primary Completion: August 19, 2022
• Study Completion: September 29, 2022
• Last Updated: January 25, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)