The Effects of the Myofascial Trigger Point Injections on Pain and Sleep Disturbance in Patients With Nocturnal Leg Cramps With Trigger Points on Gastrocnemius Muscle

Study Overview
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Brief Summary
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Nocturnal leg cramps is involuntary strong contraction of leg muscle, mostly in calves. It occurs suddenly and induces pain. Patients with frequent nocturnal leg cramps suffer from sleep disturbance in company with pain. In the present study, we examined the effects of the myofascial trigger point injections, which are known to be helpful for ease of nocturnal leg cramps, on pain and sleep disturbance in patients with nocturnal leg cramps with trigger points on gastrocnemius muscle.

Conditions
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Nocturnal Leg Cramps

Intervention / Treatment
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* Procedure: Myofascial trigger point injections on gastrocnemius muscle


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients (20-80 years of age) scheduled for myofascial trigger point injections on gastrocnemius muscle due to nocturnal leg cramps at least once a week Exclusion Criteria: Patients with no trigger points on gastrocnemius muscle, electrolyte abnormality, congenital musculoskeletal disorder, local or systemic infection, bleeding disorder or the use of anticoagulation medications, known allergy of local anesthetics, or the use of hypnotics or sedatives in the last 1 month

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Myofascial trigger point injection<br>Myofascial trigger point injection on gastrocnemius muscle | Procedure: Myofascial trigger point injections on gastrocnemius muscle<br>* On the first visit (T0), we record numeric rating scale (NRS), the frequency of cramps and insomnia severity index using questionnaires. Then we check trigger points of gastrocnemius muscle and inject lidocaine 1   2 ml each up to four points. One week later (T1) we record numeric rating scale (NRS), the frequency of cramps and insomnia severity index again, check trigger points, and if any, inject lidocaine. If the patient do not come, we get numeric rating scale (NRS), the frequency of cramps and insomnia severity index over the telephone. Two weeks after the first visit (T2), we repeat the procedure of the first visit (T0). And four weeks after the first visit (T3) we record numeric rating scale (NRS), the frequency of cramps and insomnia severity index through face-to-face interview or by telephone.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain score | Pain score measured by numeric rating scale | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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muscle cramps, trigger points, sleep disturbance