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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

Primary Purpose

Nocturnal Leg Cramps

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Myofascial trigger point injections on gastrocnemius muscle
Sponsored by
Yonsei University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nocturnal Leg Cramps focused on measuring muscle cramps, trigger points, sleep disturbance

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Severance Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Myofascial trigger point injection

Arm Description

Myofascial trigger point injection on gastrocnemius muscle

Outcomes

Primary Outcome Measures

Pain score
Pain score measured by numeric rating scale

Secondary Outcome Measures

Full Information

First Posted
March 3, 2013
Last Updated
January 26, 2015
Sponsor
Yonsei University
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1. Study Identification

Unique Protocol Identification Number
NCT01804556
Brief Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
June 2012 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nocturnal Leg Cramps
Keywords
muscle cramps, trigger points, sleep disturbance

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
13 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Myofascial trigger point injection
Arm Type
Other
Arm Description
Myofascial trigger point injection on gastrocnemius muscle
Intervention Type
Procedure
Intervention Name(s)
Myofascial trigger point injections on gastrocnemius muscle
Intervention Description
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 Measure Information:
Title
Pain score
Description
Pain score measured by numeric rating scale
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Severance Hospital
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
15710025
Citation
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.
Results Reference
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Learn more about this trial

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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