Deep Neck Flexor Exercises Versus Myofascial Release of Suboccipital Muscles in Chronic Tension-type Headache

Official 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

Overview

According to the study of the burden of diseases in 2018, tension-type headache(TTH) is the most common type of primary headache and ranks third in terms of prevalence among 328 diseases and injuries in 195 countries from 1990 to 2016. Suffering from this disorder (especially chronic type) reduces the quality of life of patients. The main objective of this study is to compare the effects of myofascial release of suboccipital muscles as a bottom-up intervention and Deep Neck Flexor(DNF) exercises with Pressure Biofeedback Unit(PBU) as a top-down intervention on headache parameters, the intensity of Forward Head Posture(FHP), disability, quality of life, and suboccipital Pressure Pain Threshold(PPT) in patients with chronic tension-type headache with forward head posture.

Detailed description

Previous studies demonstrated that suboccipital active Trigger Points(TrPs) and forward head posture were associated with Chronic Tension-Type Headache(CTTH) and they can aggravate parameters of headache in these patients. The greater suboccipital muscle contraction, as would be exexpected in greater FHP, the more the nociceptive input into the trigeminal nucleus caudalis, and the lower the headache or pain threshold, consistent with increased central sensitization; Therefore it is important to evaluate the effectiveness of interventions on FHP and suboccipital active TrPs in patients with CTTH.

The main objective of this study is to compare the effects of myofascial release of suboccipital muscles as a bottom-up intervention and deep neck flexor exercises with a pressure biofeedback unit as a top-down intervention.

Primary outcomes will be the intensity of headache and FHP. headache duration and frequency, disability, quality of life, and pain pressure threshold will be considered as secondary outcomes.

In this study, a double-dummy randomized clinical trial, 44 participants will be divided into two groups of DNF exercises with pressure biofeedback combined with sham MFR (first group) and sub-occipital MFR combined with sham DNF exercises(second group). The intervention will take place over a 4-week period, with three 1-hour sessions a week, totaling 12 treatment sessions. this study has a 6-week follow-up.

This study is a double-blind study in which the participants, the person evaluating the outcome, and the statistician of the data will be blinded to the allocation of patients to the two treatment groups.

Interventions

• Other 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 superi
• Other 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 1

Primary outcome measures

• Intensity of headache using by Numeric Pain Rating Scale(NPRS) [Time frame: 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]
• intensity of Forward Head Posture(FHP) using by Craniovertebral Angle(CVA) [Time frame: 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 measures (5)

• Duration of headache using by headache questionnaire and diary [Time frame: 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]
• Frequency of headache using by headache questionnaire and diary [Time frame: 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]
• Disability using by Henry Ford Hospital Headache Disability Inventory (HDI) questionnaire [Time frame: Change in the disability after the end of 12 treatment sessions compared to baseline and change from Baseline at 6-week follow up]
• Quality of life using by Headache Impact Test -6 (HIT-6) questionnaire [Time frame: 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]
• Pressure Pain Threshold(PPT) using by algometer [Time frame: 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 criteria

Inclusion criteria

• Age between 18 and 55 years;
• 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;
• Dosage and type of prophylactic medication have not changed in the months before the beginning of the trial;
• The participant does not intend to change the dosage and type of prophylactic medication during the study;
• CVA less than 49 degrees,
• Participants have the ability to understand and read Persian to complete the questionnaire.

Exclusion criteria

• Participants with infrequent ETTH, or other primary or secondary types of headache;
• Pain aggravated by movement of the head;
• Severe pain or significant decrease in ROM of the cervical spine;
• Previous trauma to the cervical spine;
• History of injection, surgery, severe disc protrusion, or neck or shoulder fracture that affects treatment;
• Metabolic or Neurological disorders such as Bow hunter's syndrome or epilepsy;
• Taking more than 200 pieces of morphine or other strong analgesics per month;
• Physiotherapy treatment for headache within 6 months before starting treatment;
• Joint stiffness, atherosclerosis, or advanced osteoarthritis;
• 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);
• Pregnancy;
• Spielberger State-Trait Anxiety Inventory (STAI) scores more than 85;
• Absence of two consecutive sessions and more than treatment sessions.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Publications

• Steiner TJ, Stovner LJ, Jensen R, Uluduz D, Katsarava Z; Lifting The Burden: the Global Campaign against Headache. Migraine remains second among the world's causes of disability, and first among young women: findings from GBD2019. J Headache Pain. 2020 Dec 2;21(1):137. doi: 10.1186/s10194-020-01208-0. No abstract available. PMID 33267788
• Headache Classification Committee of the International Headache Society (IHS). The International Classification of Headache Disorders, 3rd edition (beta version). Cephalalgia. 2013 Jul;33(9):629-808. doi: 10.1177/0333102413485658. No abstract available. PMID 23771276
• Stovner Lj, Hagen K, Jensen R, Katsarava Z, Lipton R, Scher A, Steiner T, Zwart JA. The global burden of headache: a documentation of headache prevalence and disability worldwide. Cephalalgia. 2007 Mar;27(3):193-210. doi: 10.1111/j.1468-2982.2007.01288.x. PMID 17381554
• GBD 2016 Disease and Injury Incidence and Prevalence Collaborators. Global, regional, and national incidence, prevalence, and years lived with disability for 328 diseases and injuries for 195 countries, 1990-2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet. 2017 Sep 16;390(10100):1211-1259. doi: 10.1016/S0140-6736(17)32154-2. PMID 28919117
• Ashina S, Buse DC, Bjorner JB, Bendtsen L, Lyngberg AC, Jensen RH, Lipton RB. Health-related quality of life in tension-type headache: a population-based study. Scand J Pain. 2021 Jan 25;21(4):778-787. doi: 10.1515/sjpain-2020-0166. Print 2021 Oct 26. PMID 33544560
• GBD 2016 Headache Collaborators. Global, regional, and national burden of migraine and tension-type headache, 1990-2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet Neurol. 2018 Nov;17(11):954-976. doi: 10.1016/S1474-4422(18)30322-3. PMID 30353868
• Fumal A, Schoenen J. Tension-type headache: current research and clinical management. Lancet Neurol. 2008 Jan;7(1):70-83. doi: 10.1016/S1474-4422(07)70325-3. PMID 18093564
• Bendtsen L. Central sensitization in tension-type headache--possible pathophysiological mechanisms. Cephalalgia. 2000 Jun;20(5):486-508. doi: 10.1046/j.1468-2982.2000.00070.x. PMID 11037746

Identifiers

NCT: NCT05383365 · IR.IUMS.REC.1400.1239

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗