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 | Completed

• 1 other identifier: 4-2012-0197
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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

Keywords

muscle cramps, trigger points, sleep disturbance

Outcome Measures

Primary Outcomes (1)

• Pain score

  Pain score measured by numeric rating scale

  4 weeks

Study Arms (1)

Myofascial trigger point injection

OTHER

Myofascial trigger point injection on gastrocnemius muscle

Procedure: Myofascial trigger point injections on gastrocnemius muscle

Interventions

Myofascial trigger point injections on gastrocnemius muscle 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.

Myofascial trigger point injection

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Severance Hospital

Seoul, Seoul, 120-752, South Korea

Location

Related Publications (1)

• 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.

  PMID: 15710025 BACKGROUND

MeSH Terms

Conditions

Sleep-Wake Transition Disorders; Muscle Cramp; Parasomnias

Condition Hierarchy (Ancestors)

Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2013
• First Posted: March 5, 2013
• Study Start: June 1, 2012
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: January 28, 2015

Record last verified: 2015-01

Locations

KR (1)