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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

NCT01804556 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2015-01-28

No results posted yet for this study

Summary

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

  • Nocturnal Leg Cramps

Interventions

PROCEDURE

Myofascial trigger point injections on gastrocnemius muscle

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.

Sponsors & Collaborators

  • Yonsei University

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-06-30
Primary Completion
2013-12-31
Completion
2013-12-31

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01804556 on ClinicalTrials.gov