Register a trial

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05383365




Registration number
NCT05383365
Ethics application status
Date submitted
21/04/2022
Date registered
20/05/2022

Titles & IDs
Public title
Deep Neck Flexor Exercises Versus Myofascial Release of Suboccipital Muscles in Chronic Tension-type Headache
Scientific title
The Effectiveness of Deep Neck Flexor Exercises in Comparison With Myofascial Release of Suboccipital Muscle on Pain and Forward Head Posture in People With Chronic Tension-type Headache and Forward Head Posture
Secondary ID [1] 0 0
IR.IUMS.REC.1400.1239
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Tension-Type Headache 0 0
Condition category
Condition code
Neurological 0 0 0 0
Other neurological disorders
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Suboccipital Myofascial Release(MFR) with sham Deep Neck Flexor(DNF)exercise
Other interventions - Deep Neck Flexor(DNF)exercise with sham Suboccipital Myofascial Release(MFR)

Experimental: Suboccipital Myofascial Release - The therapist places the supinated forearm on the bed and positions the tips of the middle three fingers inferior to the occiput bone and the head is supported by the thenar eminences

Experimental: Deep Neck Flexor Exercise - After placing the airbag of PBU under the occiput bone in the supine position and inflating it to a base pressure of 11 mmHg, the participant will increase the pressure to 12 mmHg by nodding action.


Other interventions: Suboccipital Myofascial Release(MFR) with sham Deep Neck Flexor(DNF)exercise
The treatment includes Suboccipital MFR in the supine position.The therapist places the supinated forearm on the bed and positions the tips of the middle three fingers inferior to the occiput bone and the head is supported by the thenar eminences.The therapist will develop a line of tension through the suboccipital tissues by supinating the forearms and pulling apart two hands from each other;Then, for the second level in the first position of hands,pressure is applied to the anterior and superior direction.The pressure is held and increased until the therapist feels the decrease of muscle tone.These techniques last 10 minutes.

Another intervention in this group is the sham DNF exercise with a Pressure Biofeedback Unit(PBU).Considering that minimum detective change with PBU is 15 mmHg; After placing the airbag of PBU under the occiput bone in the supine position and inflating it to a base pressure of 11 mmHg,the participant will increase the pressure to 12 mmHg by nodding action.

Other interventions: Deep Neck Flexor(DNF)exercise with sham Suboccipital Myofascial Release(MFR)
The treatments include the DNF exercise with a PBU. The treatment is performed in the supine position and the airbag is placed under the occiput bone and is inflated to a base pressure of 20 mmHg. The participant will increase and hold the pressure to a special point by nodding action. The exercise is repeated for 3 sets, in each set 2 mm Hg is added to the pressure. The pressure will be increased from 22 to 32 mm Hg during 4-week of treatment, and each goal is held for 10 seconds and repeated 10 times. There will be 5 sec of rest between each repetition and 2 min of rest between each set.

Another intervention in this group is sham MFR. The therapist's hands will be placed only inferior to the occipital bone and a superficial touch is applied without any upward or lateral pressure. sham treatment in this group, like the opposite group, lasts 10 minutes.
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Intensity of headache using by Numeric Pain Rating Scale(NPRS)
Timepoint [1] 0 0
Change in the intensity of headache after the end of 12 treatment sessions compared to baseline and change from Baseline at 6-week follow up
Primary outcome [2] 0 0
intensity of Forward Head Posture(FHP) using by Craniovertebral Angle(CVA)
Timepoint [2] 0 0
Change in the intensity of Forward Head Posture after the end of 12 treatment sessions compared to baseline and change from Baseline at 6-week follow up
Secondary outcome [1] 0 0
Duration of headache using by headache questionnaire and diary
Timepoint [1] 0 0
Change in the duration of headache after the end of 12 treatment sessions compared to baseline and change from Baseline at 6-week follow up
Secondary outcome [2] 0 0
Frequency of headache using by headache questionnaire and diary
Timepoint [2] 0 0
Change in the frequency of headache after the end of 12 treatment sessions compared to baseline and change from Baseline at 6-week follow up
Secondary outcome [3] 0 0
Disability using by Henry Ford Hospital Headache Disability Inventory (HDI) questionnaire
Timepoint [3] 0 0
Change in the disability after the end of 12 treatment sessions compared to baseline and change from Baseline at 6-week follow up
Secondary outcome [4] 0 0
Quality of life using by Headache Impact Test -6 (HIT-6) questionnaire
Timepoint [4] 0 0
Change in the quality of life after the end of 12 treatment sessions compared to baseline and change from Baseline at 6-week follow up
Secondary outcome [5] 0 0
Pressure Pain Threshold(PPT) using by algometer
Timepoint [5] 0 0
Change in the pain pressure threshold after the end of 12 treatment sessions compared to baseline and change from Baseline at 6-week follow up

Eligibility
Key inclusion criteria
1. Age between 18 and 55 years;
2. based on ICHD-3, Headache that occurs 15 days per month and lasts on average for >3 months (180 days per year), lasting hours to days, or unremitting, and has at least two of the following four characteristics recognized as CTTH: bilateral location, pressing or tightening (non-pulsating) quality, mild or moderate intensity, not aggravated by routine physical activity such as walking or climbing stairs and both of the following: no more than one of photophobia, phonophobia or mild nausea, neither moderate or severe nausea nor vomiting;
3. Dosage and type of prophylactic medication have not changed in the months before the beginning of the trial;
4. The participant does not intend to change the dosage and type of prophylactic medication during the study;
5. CVA less than 49 degrees,
6. Participants have the ability to understand and read Persian to complete the questionnaire.
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Participants with infrequent ETTH, or other primary or secondary types of headache;
2. Pain aggravated by movement of the head;
3. Severe pain or significant decrease in ROM of the cervical spine;
4. Previous trauma to the cervical spine;
5. History of injection, surgery, severe disc protrusion, or neck or shoulder fracture that affects treatment;
6. Metabolic or Neurological disorders such as Bow hunter's syndrome or epilepsy;
7. Taking more than 200 pieces of morphine or other strong analgesics per month;
8. Physiotherapy treatment for headache within 6 months before starting treatment;
9. Joint stiffness, atherosclerosis, or advanced osteoarthritis;
10. Manual contraindication includes: (a)The participant has substance or alcohol abuse; (b)For whatever reason, the participant does not want to be touched by the therapist; (c)Symptoms are severe and irritating; (d)Underlying diseases (such as rheumatoid arthritis) or metabolic disorders (such as osteoporosis or soft tissue laxity of the treatment area);
11. Pregnancy;
12. Spielberger State-Trait Anxiety Inventory (STAI) scores more than 85;
13. Absence of two consecutive sessions and more than treatment sessions.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/11/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2026
Actual
Sample size
Target
44
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Primary sponsor type
Other
Name
Iran University of Medical Sciences
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Mobina Ahmadi, MSc student
Address 0 0
MSc student
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Mobina Ahmadi, MSc student
Address 0 0
Country 0 0
Phone 0 0
00989039182326
Fax 0 0
Email 0 0
m.oahmadi@ymail.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
The data sets of this study will be available on a reasonable request to the corresponding author

Supporting document/s available: Study protocol
When will data be available (start and end dates)?
starting 6 months after the publication
Available to whom?
The data will be available for physical therapists working in academic institutions and also clinicians working in the field of musculoskeletal disorders and headaches. The raw data and results of this study can be used in future relevant systematic reviews. Thus, the raw data and results of this study will be available for researchers working in the field of tension-type headache. Applicants can contact Mobina Ahmadi by Email.

Email Address:M.oahmadi@ymail.com Applicants should explain their project and how the data/documents of the study will be used in their project in detail. Then, the data/documents files will be sent by email to applicants on request. This process may take 10-12 working days.
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05383365