Clinical Trials Directory

Trials / Completed

CompletedNCT01804556

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
13 (actual)
Sponsor
Yonsei University · Academic / Other
Sex
All
Age
20 Years – 80 Years
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
PROCEDUREMyofascial trigger point injections on gastrocnemius muscleOn 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.

Timeline

Start date
2012-06-01
Primary completion
2013-12-01
Completion
2013-12-01
First posted
2013-03-05
Last updated
2015-01-28

Locations

1 site across 1 country: South Korea

Source: ClinicalTrials.gov record NCT01804556. Inclusion in this directory is not an endorsement.