Completed

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

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What is being tested

Myofascial trigger point injections on gastrocnemius muscle

Procedure
Who is being recruted

Mental Disorders+9

+ Muscular Diseases

+ Musculoskeletal Diseases

From 20 to 80 Years
+6 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: June 2012
See protocol details

Summary

Principal SponsorYonsei University
Last updated: January 28, 2015
Sourced from a government-validated database.Claim as a partner

Study start date: June 1, 2012

Actual date on which the first participant was enrolled.

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.

NCT01804556
Principal SponsorYonsei University
Last updated: January 28, 2015
Sourced from a government-validated database.Claim as a partner

Protocol

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

13 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 20 to 80 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Mental DisordersMuscular DiseasesMusculoskeletal DiseasesNervous System DiseasesNeurologic ManifestationsSigns and SymptomsSleep Wake DisordersPathological Conditions, Signs and SymptomsNeuromuscular ManifestationsMuscle CrampParasomniasSleep-Wake Transition Disorders

Criteria

1 inclusion criteria required to participate
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
5 exclusion criteria prevent from participating
Patients with no trigger points on gastrocnemius muscle
congenital musculoskeletal disorder
electrolyte abnormality
known allergy of local anesthetics, or the use of hypnotics or sedatives in the last 1 month
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Myofascial trigger point injection on gastrocnemius muscle

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Severance Hospital

Seoul, South KoreaOpen Severance Hospital in Google Maps
CompletedOne Study Center