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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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ClinicalTrials.gov Identifier: NCT01804556
Recruitment Status : Completed
First Posted : March 5, 2013
Last Update Posted : January 28, 2015
Sponsor:
Information provided by (Responsible Party):
Yonsei University

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.

Condition or disease Intervention/treatment Phase
Nocturnal Leg Cramps Procedure: Myofascial trigger point injections on gastrocnemius muscle Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : June 2012
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Muscle Cramps

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Pain score [ Time Frame: 4 weeks ]
    Pain score measured by numeric rating scale



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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01804556


Locations
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Korea, Republic of
Severance Hospital
Seoul, Korea, Republic of, 120-752
Sponsors and Collaborators
Yonsei University
Publications:
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Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT01804556    
Other Study ID Numbers: 4-2012-0197
First Posted: March 5, 2013    Key Record Dates
Last Update Posted: January 28, 2015
Last Verified: January 2015
Keywords provided by Yonsei University:
muscle cramps, trigger points, sleep disturbance
Additional relevant MeSH terms:
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Sleep-Wake Transition Disorders
Nervous System Diseases
Parasomnias
Sleep Wake Disorders
Mental Disorders