NCT05883813

Brief Summary

Headache disorder characterized by recurrent headache are among the most common disoredrs of the nervous system. Tension type headache is widely recognized kind of headache that affects 80% of the individuals. Its underlying cause has not been clearly distinguished. It is managed both pharmacology and non-pharmacology which includes dry needling, acupuncture, manual techniques and massage. Several studies conducted which showed that both the soft tissue muscle inhibition and joint mobilization techniques are effective in decreasing pain. But there is lack of evidence which shows combined effects of soft tissue muscle inhibition and sustained natural apophyseal glides(SNAGS) in chronic tension type headache. so this study will compare the effects of soft tissue muscle release and SNAGS on pain intensity and cervical range of motion.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2023

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 22, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 1, 2023

Completed
14 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2023

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2023

Completed
Last Updated

June 1, 2023

Status Verified

May 1, 2023

Enrollment Period

6 months

First QC Date

May 22, 2023

Last Update Submit

May 22, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • cervical range of motion

    The cervical range of motion will be measured by using goniometer. The patient will be in sitting position. For flexion and extension, the fulcrum will be placed on external auditory meatus, the stationary arm will be vertical to the ground with moving arm aligned parallel with the base of the ear. For side bending, the fulcrum will be placed on C7 vertebrae, the stationary arm perpendicular to the ground and moving arm parallel to the external occipital protuberence. For rotation, the fulcrum will be placed on the central cranial aspect of head, stationary arm parallel to the acromion process and moving arm align with tip of the nose. The angle between the stationary and moving arm will be measured.

    Immediate after treatment

Secondary Outcomes (2)

  • Pain intensity

    Immediate after treatment

  • Blood pressure

    Immediate after treatment

Study Arms (2)

Group 1

ACTIVE COMPARATOR

suboccipital muscle release for 10 mins + 5 min general warm up exercises + 10 min hot pack + 10 min TENS + trapezius stretching with 3 sec hold and 5 reps

Procedure: suboccipital muscle releaseProcedure: Supplemental therapy

Group 2

EXPERIMENTAL

suboccipital muscle release for 10 mins + SNAGS: 3 glides with 10 sec hold of each glide + 5 min general warm up exercises + 10 min hot pack + 10 min TENS + trapezius stretching with 10 sec hold and 5 reps

Procedure: sustained natural apophyseal glides (SNAGS)Procedure: suboccipital muscle releaseProcedure: Supplemental therapy

Interventions

SNAGS will be given with patient in sitting position and the therapist will be standing behind the patient. The therapist will place the thumb on the spinous process of the vertebra. Move spinous process upward towards the eyeball direction \& maintain the glide and ask the patient to turn (rotation) his head slowly in painful direction, sustain the mobilization until head turn to the midline. Three repetitions of each glide will be given and each glide will be maintained for 10 seconds at end range.

Group 2

Sub-occipital muscle release will be applied with the patient in the supine position with the eyes closed and the physiotherapist's hands placed under the patient's head, in contact with the sub-occipital muscles. The physiotherapist progressively increased the pressure exerted during the 10 minutes of treatment.

Group 1Group 2

General warm-up exercises, TENS, hot pack, trapezius stretching

Group 1Group 2

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • years old
  • Male and Female
  • International classification of headache disorders-3 diagnosis:
  • Headache occurring on 15 days/month on average for \>3 months (180 days/year),
  • Lasting hours to days, or unremitting -At least two of the following four characteristics:-
  • Bilateral location
  • Pressing or tightening (non-pulsating) quality
  • Mild or moderate intensity
  • Not aggravated by routine physical activity such as walking or climbing stairs
  • Both of the following:
  • No more than one of photophobia, phonophobia or mild nausea
  • Neither moderate or severe nausea nor vomiting
  • Not better accounted for by another ICHD-3 diagnosis.

You may not qualify if:

  • Patients with other types of primary or secondary headache e.g cervicogenic headache
  • History of trauma to the cervical spine
  • Vertigo, dizziness, uncompensated neck tension
  • Spurling test positive
  • Flexion compression test positive
  • Extension compression test positive
  • Cervical flexion rotation test positive
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fauji Foundation Hospital

Rawalpindi, Punjab Province, 46000, Pakistan

Location

MeSH Terms

Conditions

Tension-Type Headache

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
The participant does not know about the group in which he is included.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This study is randomized controlled trial which consist of 2 groups. One group will be given suboccipital muscle release. Second group will be given SNAGS along with sub-occipital muscle release. All the groups were recruited concurrently.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 22, 2023

First Posted

June 1, 2023

Study Start

January 1, 2023

Primary Completion

June 15, 2023

Study Completion

July 1, 2023

Last Updated

June 1, 2023

Record last verified: 2023-05

Locations