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Extracorporeal Shock Wave Therapy Treatment for Nocturnal Leg Cramps

Primary Purpose

Nocturnal Leg Cramps

Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Extracorporeal shock wave therapy
General physical therapy
Sponsored by
China Medical University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nocturnal Leg Cramps focused on measuring myofascial trigger points, nocturnal leg cramps, extracorporeal shock wave therapy

Eligibility Criteria

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

Inclusion Criteria:

  1. ≥ 20 y/o patients with NLCs: (1) 4 times/week, last 2 weeks; (2) Occurred in nighttime or resting time of daytime
  2. Patients with MTrPs on gastrocnemius (According to the diagnostic criteria proposed by Simons & Travell)

Exclusion Criteria:

  1. (1) Taking medication for leg cramps (eg. Quinine, Magnesium oxide); (2) Other drugs that affect research and evaluation (eg. diuretics, statins, calcium channel blockers, anticonvulsants)
  2. Congenital lower limb musculoskeletal diseases, Lower limb or spine surgery
  3. Uncommunicated or cognitive impaired
  4. Patients refused to be recruited

Sites / Locations

  • China Medical University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Extracorporeal shock wave therapy and general physical therapy

Only general physical therapy

Arm Description

In this arm, the subjects will receive the intervention of extracorporeal shock wave therapy and general physical therapy 3 times a week for 2 weeks, in total 6 times treatments and will be arrange to take efficacy two assessment on 1 week and 2 weeks after 6 times treatments separately.

In this arm, the subjects will only receive the intervention of general physical therapy 3 times a week for 2 weeks, in total 6 times treatments and will be arrange to take efficacy two assessment on 1 week and 2 weeks after 6 times treatments separately.

Outcomes

Primary Outcome Measures

The frequency of nocturnal leg cramps (FC)
Ask participants to describe the frequency of nocturnal leg cramps (NLCs) in the last week. The frequency of occurrence is recorded on an average of several times a day (times/day). The frequency of nocturnal leg cramps (FC) can be used as a tracking and indicator of treatment.

Secondary Outcome Measures

Visual Analog Scales (VAS)
The visual analogue scale or visual analog scale (VAS) is a psychometric response scale which can be used in questionnaires. This tool used to help a person rate the intensity of certain sensations and feelings, such as pain. A straight line of 100mm is actually marked with 0 mm on the far left and 100mm on the far right. Two faces are drawn on both ends. Explain to the patient that 0 mm means no pain and 100 mm means very painful. From the left end The right shift indicates more and more pain. Take a pen and let the patient draw a short line vertically on the line, representing his painful position, and record the measured cm value. In this test, if the score of the subject decreases, it can represent the treatment is helpful for the improvement of the patient's pain.
Pressure Pain Threshold (PPT)
Pressure pain threshold (PPT) is defined as the minimum force applied which induces pain. This measure has proven to be commonly useful in evaluating tenderness symptom
Range of Motion of knee and ankle joint
Range of motion of knee and ankle joint will be limited when the calf muscle with active myofasical trigger point. To record range of motion of knee and ankle joint for tracking the efficacy of treatment.
Muscle tone
Muscle tone is the muscle's resistance to passive stretch during resting state. The measuring tool called Myotone will calculate three parameters such as tone, elasticity and stiffness automatically and get a value to represent the muscle tone. If the value decrease, it can represent the treatment is helpful for the subjective muscle relax.
Pittsburgh sleep quality index (PSQI)
The Pittsburgh sleep quality index (PSQI) is currently the most effective assessment tool for assessing sleep quality and status in adults. It can be used to assess and track changes in sleep quality after treatment. The Pittsburgh Sleep Quality Assessment (PSQI) content includes (1) subjective sleep quality, (2) sleep latency, (3) sleep duration, (4) sleep efficiency, (5) sleep disturbance, (6) daytime function, and (7) the condition of using sleep pills. The score of the item is from 0 to 3 points, and the total score is from 0 to 21 points. The higher the score means the worse the quality of sleep. If the total score is greater than 5 points that means the poor quality of sleep.

Full Information

First Posted
March 5, 2019
Last Updated
March 7, 2019
Sponsor
China Medical University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03864770
Brief Title
Extracorporeal Shock Wave Therapy Treatment for Nocturnal Leg Cramps
Official Title
Effectiveness of Extracorporeal Shockwave Therapy on the Patients With Nocturnal Leg Cramps - Possible Related to Myofascial Trigger Point in the Gastrocnemius Muscle
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Unknown status
Study Start Date
March 5, 2019 (Anticipated)
Primary Completion Date
December 5, 2019 (Anticipated)
Study Completion Date
February 4, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
China Medical University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Nocturnal leg cramps (NLCs) are often described as a symptom of sudden and involuntary muscle contraction at night, which often affects sleep quality due to pain and tight discomfort in the thigh, calf and foot. The investigator performed extracorporeal shock wave therapy (ESWT). This experiment used a randomized experiment to assess the immediate, short-term and long-term effects of extracorporeal shock wave therapy on patients with nocturnal leg cramps.
Detailed Description
Nocturnal leg cramps (NLCs) are often described as a symptom of sudden and involuntary muscle contraction at night, which often affects sleep quality due to pain and tight discomfort in the thigh, calf and foot. The pathophysiology of nocturnal leg cramps is unclear, but it is generally considered to be associated with excitability lower motor neurons, sleep posture at night, leg muscle fatigue, nerve disability or damage (eg, Parkinson's disease), metabolic diseases (eg : hyperphosphatemia). Generally, quinine or magnesium oxide is the most commonly used pharmacological treatment. The common non-drug treatments are stretching exercise, massage or hot therapy, but there is not enough evidence to indicate which treatment is specific effective. In a previous study, they proposed that nocturnal leg cramps may be associated with myofascial trigger points (MTrPs) of the gastrocnemius. Other studies have also proposed that extracorporeal shock wave therapy (ESWT) applying to the MTrPs of the upper trapezius muscle could improve cervicogenic headache. We will conduct a randomized parallel study to investigate the efficacy of ESWT on nocturnal leg cramps. Participants will be randomized into two groups: one is only general physical therapy (gPT) and the other one is ESWT + gPT. The outcome measurement tools including the frequency of nocturnal leg cramps, visual analog scale (VAS), pain pressure threshold (PPT) and muscle tone in the gastrocnemius, range of motion of knee and ankle, and quality of sleep questionnaire were used to compare two groups with regard to the pain intensity, quality of sleep, and overall satisfaction in subjects with nocturnal leg cramps.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nocturnal Leg Cramps
Keywords
myofascial trigger points, nocturnal leg cramps, extracorporeal shock wave therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Extracorporeal shock wave therapy and general physical therapy
Arm Type
Experimental
Arm Description
In this arm, the subjects will receive the intervention of extracorporeal shock wave therapy and general physical therapy 3 times a week for 2 weeks, in total 6 times treatments and will be arrange to take efficacy two assessment on 1 week and 2 weeks after 6 times treatments separately.
Arm Title
Only general physical therapy
Arm Type
Active Comparator
Arm Description
In this arm, the subjects will only receive the intervention of general physical therapy 3 times a week for 2 weeks, in total 6 times treatments and will be arrange to take efficacy two assessment on 1 week and 2 weeks after 6 times treatments separately.
Intervention Type
Device
Intervention Name(s)
Extracorporeal shock wave therapy
Intervention Description
Extracorporeal shock wave therapy is a mechanical sound wave that generates energy by extremely high-frequency vibration to compress the medium. Low-energy extracorporeal shock waves can be used for cell regeneration and pain control therapy; medium-high energy can be used to treat patients with poor bone healing; high-energy can be used to lithotrite. In recent years, extracorporeal shock waves have been applied on the musculoskeletal diseases, such as: epicondylitis, plantar fasciitis, chronic pelvic pain, chronic heel pain syndrome, lymphedema, burns, pressure sores, calcific tendinitis and myofascial pain syndrome. This treatment is a non-invasive and safe treatment.
Intervention Type
Procedure
Intervention Name(s)
General physical therapy
Intervention Description
The general physical therapies such as: thermotherapy, straight leg raise (SLR), transcutaneous electrical nerve stimulation (TENS) for treatment on calf muscle.
Primary Outcome Measure Information:
Title
The frequency of nocturnal leg cramps (FC)
Description
Ask participants to describe the frequency of nocturnal leg cramps (NLCs) in the last week. The frequency of occurrence is recorded on an average of several times a day (times/day). The frequency of nocturnal leg cramps (FC) can be used as a tracking and indicator of treatment.
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Visual Analog Scales (VAS)
Description
The visual analogue scale or visual analog scale (VAS) is a psychometric response scale which can be used in questionnaires. This tool used to help a person rate the intensity of certain sensations and feelings, such as pain. A straight line of 100mm is actually marked with 0 mm on the far left and 100mm on the far right. Two faces are drawn on both ends. Explain to the patient that 0 mm means no pain and 100 mm means very painful. From the left end The right shift indicates more and more pain. Take a pen and let the patient draw a short line vertically on the line, representing his painful position, and record the measured cm value. In this test, if the score of the subject decreases, it can represent the treatment is helpful for the improvement of the patient's pain.
Time Frame
1 day
Title
Pressure Pain Threshold (PPT)
Description
Pressure pain threshold (PPT) is defined as the minimum force applied which induces pain. This measure has proven to be commonly useful in evaluating tenderness symptom
Time Frame
1 day
Title
Range of Motion of knee and ankle joint
Description
Range of motion of knee and ankle joint will be limited when the calf muscle with active myofasical trigger point. To record range of motion of knee and ankle joint for tracking the efficacy of treatment.
Time Frame
1 day
Title
Muscle tone
Description
Muscle tone is the muscle's resistance to passive stretch during resting state. The measuring tool called Myotone will calculate three parameters such as tone, elasticity and stiffness automatically and get a value to represent the muscle tone. If the value decrease, it can represent the treatment is helpful for the subjective muscle relax.
Time Frame
1 day
Title
Pittsburgh sleep quality index (PSQI)
Description
The Pittsburgh sleep quality index (PSQI) is currently the most effective assessment tool for assessing sleep quality and status in adults. It can be used to assess and track changes in sleep quality after treatment. The Pittsburgh Sleep Quality Assessment (PSQI) content includes (1) subjective sleep quality, (2) sleep latency, (3) sleep duration, (4) sleep efficiency, (5) sleep disturbance, (6) daytime function, and (7) the condition of using sleep pills. The score of the item is from 0 to 3 points, and the total score is from 0 to 21 points. The higher the score means the worse the quality of sleep. If the total score is greater than 5 points that means the poor quality of sleep.
Time Frame
1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: ≥ 20 y/o patients with NLCs: (1) 4 times/week, last 2 weeks; (2) Occurred in nighttime or resting time of daytime Patients with MTrPs on gastrocnemius (According to the diagnostic criteria proposed by Simons & Travell) Exclusion Criteria: (1) Taking medication for leg cramps (eg. Quinine, Magnesium oxide); (2) Other drugs that affect research and evaluation (eg. diuretics, statins, calcium channel blockers, anticonvulsants) Congenital lower limb musculoskeletal diseases, Lower limb or spine surgery Uncommunicated or cognitive impaired Patients refused to be recruited
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
LI-Wei Chou, PhD
Phone
+886-4-22052121
Ext
2381
Email
chouliwe@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yueh-Ling Hsieh, PhD
Phone
04-22053366
Ext
7312
Email
sherrie@mail.cmu.edu.tw
Facility Information:
Facility Name
China Medical University Hospital
City
Taichung
ZIP/Postal Code
999079
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chou Li-Wei, PhD
Phone
+886-4-22052121
Ext
2381
Email
chouliwe@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
33998664
Citation
Hawke F, Sadler SG, Katzberg HD, Pourkazemi F, Chuter V, Burns J. Non-drug therapies for the secondary prevention of lower limb muscle cramps. Cochrane Database Syst Rev. 2021 May 17;5(5):CD008496. doi: 10.1002/14651858.CD008496.pub3.
Results Reference
derived

Learn more about this trial

Extracorporeal Shock Wave Therapy Treatment for Nocturnal Leg Cramps

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