High Power Laser on Suboccipital Myoelectrical Activities and Quality of Life in Patients With Cervicogenic Headache

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• Post-Traumatic Headache 192

Post-Traumatic Headache

192 studies on the registry are indexed under Post-Traumatic Headache; 54 are open to participants now.

This study's planned enrollment of 40 is close to the median of 44 across 169 interventional studies indexed under Post-Traumatic Headache.

Lead sponsor

Cairo University is the lead sponsor of 4,941 studies on the registry; 1,458 are open to participants now.

Of its 37 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Study arms

• Experimental
  High power laser therapy and conventional physical therapy program

  The participants will receive high power laser therapy (HPLT) for 15 minutes in addition to a conventional physical therapy program (therapeutic exercise) for 45 minutes three a week for six weeks.

  Device: High-power laser therapy · Other: Conventional physical therapy program

• Active comparator
  Placebo high power laser therapy and conventional physical therapy program

  The participants will receive placebo high power laser therapy (HPLT) for 15 minutes in addition to a conventional physical therapy program (therapeutic exercise) for 45 minutes three a week for six weeks.

  Device: Placebo (PL) high power laser · Other: Conventional physical therapy program

Interventions

• DeviceHigh-power laser therapy

  High power laser therapy (HPLT) with a neodymium-yttrium aluminum garnet laser with a pulsating waveform produced by a ( Hilterapia device , ASA, Arcugnano, Vicenza, Italy). It will be set at the following parameters: Nd:YAG laser with pulsed emission (1064 nm), very high peak powers with average power 6 W, high levels of fluency (760 mJ/cm energy density), short pulse duration (250 μs), low frequency (10-40 Hz), and 5-cm probe diameter for 15 minutes. The scanning will be performed longitudinally \&transversely from the C3 to C7 posterior neck in the paraspinal region, upper back, inter-scapular area, trapezius, sternocleidomastoid muscles, and posterior \& lateral shoulder areas

• DevicePlacebo (PL) high power laser

  laser probe scanning will be applied to the same areas as that applied in the HPLT procedure. PL will be applied while the lights of the device will be on, with no current flowing through the device. Placebo therapy will be applied at the same frequency as HPLT (Three sessions a week for six weeks for a total of 18 sessions; one session will be lasted 15 minutes).

• OtherConventional physical therapy program

  A specific program of 45-min exercise of three sessions a week for six weeks for a total of 18 sessions. Corrective exercises will be performed initially by stretching exercises for(suboccipital, upper trapezeius, scalene, levator scapulae, sternocleidomastoid, pectoralis major/minor muscles) will be given four repetitions with 30 second hold. each with 3 seconds rest between each stretch Then, strengthening exercises will be performed initially in an isometric manner for weak muscles (deep cervical flexors, rhomboidus, and lower trapezeius muscles) will be done initially without weight and afterward by using Theraband and dumbells. All patients will be instructed to achieve three sets of 12 repetitions of the strengthening exercises (isometrics exercises) with 1 to 2 minutes rest in between each set. Contraction will be held for 5 seconds/repetitions. 10-20 repetitions for strengthening exercises and 3 sets of 30 repetitions for endurance exercise

Primary outcomes

1. Myoelectrical activity of suboccipital muscle

   Needle electromyography (EMG, Micromed, made in Italy) is a definitive invasive technique that allows an objective evaluation of muscle activity. Activation pattern of the suboccipital muscle mainly the rectus capitis posterior muscles will be recorded and analyzed. The skin is cleaned with alcohol to reduce skin impedance. A Concentric needle is inserted in the rectus capitis posterior muscles, positioned caudad, at a point 1-2cm lateral to the midline at the level of the approximation of the posterior arch of C1. at approximately 80 degrees from an imaginary line drawn parallel to the surface of the skin in the mid-sagital plane. The patient performed extension delivering maximum voluntary contraction against therapist hand. Reference electrode is placed just above the middle of the spine of the right scapula or over the forehead. Data will be represented as interference patterns (graphics), analyzed and compared before and after the intervention for all participants in the study.

   Time frame: 6 weeks

2. Neck Disability Index (NDI)

   The NDI will be used to assess neck pain and quality of life for all participants before and after the treatment program. It is consisted of 10 items with six potential responses per item relating to pain severity, headache, attention, and various physical activities (lifting, personal care, recreation, work, driving, reading, and sleeping). Each item's score ranges from 0 to 5. The maximum possible total score is 50, which is translated to a percentage. Higher scores indicate a greater degree of impairment. The NDI has been demonstrated to be a valid, had stable psychometric characteristics and accurate questionnaire for people suffering from neck pain

   Time frame: 6 weeks

3. Quality of life (QoL) assessment

   The SF-36 questionnaire will be used to assess QoL for all participants before and after the end of the study program. It is a self-administered questionnaire containing 36 items which takes about five minutes to complete. It measures health on eight multi-item dimensions, covering physical functioning, role limitation due to physical health, bodily pain, general health perception, vitality, social functioning, role limitation due to emotional problems and perceived mental health. Each domain contains number of items. The answers to each question are extrapolated to a standardized set of answers, and the results are transferred to a scale of 0-100, where 0 represents the worst state of health measured, and 100 represents the best state of health measured. It has good validity and reliability and can be used as a general questionnaire to assess quality of life.

   Time frame: 6 weeks

Secondary outcomes

1. Pain intensity

   Visual analogue scale (VAS) will be used to assess pain intensity for all participants before and after the treatment program. It is a straight line, and its length is 10 cm, ranging from no pain or discomfort (zero), to the worst pain (10) that the patient could feel. it is a valid scale and has good validity and reliability.

   Time frame: 6 weeks

2. Headache impact test-6 (The HIT-6)

   The six-item Headache Impact Test (HIT-6) from Quality Metric is a patient-reported outcome (PRO) tool used to capture the impact of headaches and headache treatments on functional health and wellbeing. The HIT-6 addresses six core domains affected by headaches: pain. social Functioning, role Functioning, cognitive Functioning, vitality and psychological Stress. Each item is answered on a 5-point Likert scale (6 = never, 8 = rarely, 10 = sometimes, 11 = very often, 13 = always). The final score is obtained from a simple summation of the six items. The HIT-6 total score ranges between 36 and 78, with larger scores reflecting greater impact. Four categories have been derived to aid in the interpretation of HIT-6 scores: scores ≤49 represent little or no impact; scores between 50 and 55 represent mild impact; scores between 56 and 59 represent moderate impact; and scores ≥60 indicate severe impact.

   Time frame: 6 weeks