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

NCT ID: NCT01804556

Last Updated: 2015-01-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-06-30
• Study Completion Date: 2013-12-31

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Myofascial trigger point injection

Myofascial trigger point injection on gastrocnemius muscle

Group Type: OTHER

Myofascial trigger point injections on gastrocnemius muscle

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yonsei University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Severance Hospital

Seoul, Seoul, South Korea

Countries

South Korea

References

Al-Shaikh B, George William M, Van Zundert AA. Using atmospheric pressure to inflate the cuff of the Portex Laryngeal Mask. Anaesthesia. 2005 Mar;60(3):296-7. doi: 10.1111/j.1365-2044.2005.04135.x. No abstract available.

Reference Type: BACKGROUND

PMID: 15710025 (View on PubMed)

Other Identifiers

4-2012-0197

Identifier Type: -

Identifier Source: org_study_id