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

January 26, 2015 updated by: Yonsei University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

13

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: Myofascial trigger point injection
Myofascial trigger point injection on gastrocnemius muscle
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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yonsei University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2012

Primary Completion (ACTUAL)

December 1, 2013

Study Completion (ACTUAL)

December 1, 2013

Study Registration Dates

First Submitted

March 3, 2013

First Submitted That Met QC Criteria

March 3, 2013

First Posted (ESTIMATE)

March 5, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

January 28, 2015

Last Update Submitted That Met QC Criteria

January 26, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4-2012-0197

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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