Nocturnal Leg CrampsNCT03864770
Extracorporeal Shock Wave Therapy Treatment for Nocturnal Leg Cramps
A study testing Extracorporeal shock wave therapy and General physical therapy in people with Nocturnal Leg Cramps, run by China Medical University Hospital at 1 site in Taiwan.
Trial 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). Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Nocturnal Leg Cramps
- What is being tested?
- Extracorporeal shock wave therapy and General physical therapy
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTaiwan
- Study dates
- 5 Mar 2019to 4 Feb 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 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)
Who cannot join
- (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
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
China Medical University Hospital
Taichung, 999079
Chou Li-Wei, PhD, +886-4-22052121 ext. 2381, chouliwe@gmail.com
About this study
Official title: Effectiveness of Extracorporeal Shockwave Therapy on the Patients With Nocturnal Leg Cramps - Possible Related to Myofascial Trigger Point in the Gastrocnemius Muscle
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.
Read the 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.
- Conditions
- Nocturnal Leg Cramps
- Being tested
- Extracorporeal shock wave therapy, General physical therapy
- Keywords
- myofascial trigger points, nocturnal leg cramps, extracorporeal shock wave therapy
- Medical subject headings
- Sleep-Wake Transition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extracorporeal shock wave therapyDevice
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.
General physical therapyProcedure or surgery
The general physical therapies such as: thermotherapy, straight leg raise (SLR), transcutaneous electrical nerve stimulation (TENS) for treatment on calf muscle.
| Study group | Role | What they receive |
|---|---|---|
| Extracorporeal shock wave therapy and general physical therapy | Experimental | 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. Receives: Device: Extracorporeal shock wave therapy; Procedure: General physical therapy |
| Only general physical therapy | Active comparator | 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. Receives: Procedure: General physical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 day
Secondary outcomes (5)
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.
Measured: 1 day
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
Measured: 1 day
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.
Measured: 1 day
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.
Measured: 1 day
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.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2019
- Study start5 Mar 2019 (estimated)
- Primary completion5 Dec 2019 (estimated)
- Study completion4 Feb 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Nocturnal Leg CrampsStudies of the same condition, open and under way.
- More trials run by China Medical University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Li-Wei Chou, China Medical University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03864770
- Sponsor's protocol ID
- CMUH108-REC2-006
- Status last verified
- Mar 2019
- First submitted
- 5 Mar 2019
- Last updated
- 11 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 33998664
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Extracorporeal Shockwave Therapy on the Patients With Nocturnal Leg Cramps - Possible Related to Myofascial Trigger Point in the Gastrocnemius Muscle
- ClinicalTrials.gov ID
- NCT03864770
- Acronym / sponsor ID
- CMUH108-REC2-006
- Conditions
- Nocturnal Leg Cramps
- Keywords
- myofascial trigger points, nocturnal leg cramps, extracorporeal shock wave therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Study start
- 5 Mar 2019 (estimated)
- Primary completion
- 5 Dec 2019 (estimated)
- Study completion
- 4 Feb 2020 (estimated)
- First posted
- 6 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Extracorporeal shock wave therapy and general physical therapy | Experimental | Device: Extracorporeal shock wave therapy, Procedure: General physical therapyIn 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. |
| Only general physical therapy | Active comparator | Procedure: General physical therapyIn 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. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- ≥ 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)
Key exclusion criteria (4 listed)
- (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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Extracorporeal shock wave therapyExtracorporeal 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. | Device | Extracorporeal shock wave therapy and general physical therapy |
| General physical therapyThe general physical therapies such as: thermotherapy, straight leg raise (SLR), transcutaneous electrical nerve stimulation (TENS) for treatment on calf muscle. | Procedure or surgery | Extracorporeal shock wave therapy and general physical therapy, Only general physical therapy |
Primary outcome
The frequency of nocturnal leg cramps (FC)
Time frame: 1 day
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.
5 secondary outcomes
Visual Analog Scales (VAS)
Time frame: 1 day
Pressure Pain Threshold (PPT)
Time frame: 1 day
Range of Motion of knee and ankle joint
Time frame: 1 day
Muscle tone
Time frame: 1 day
Pittsburgh sleep quality index (PSQI)
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2019.
- Derived from this study: PubMed 33998664Hawke 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.
- Individual participant dataSharing planned: Undecided
Related trials for Nocturnal Leg Cramps
Recruiting
The Effect of a Daily Magnesium and Melatonin Supplement on Sleep Quality in People With Nighttime Leg Cramps
Poor Sleep Quality, Leg Cramps, Nocturnal
Not yet recruiting
Weighted Blanket in Pregnancy
Leg Cramps, Nocturnal, Poor Sleep Quality
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Extracorporeal shock wave therapy and General physical therapy in people with Nocturnal Leg Cramps, run by China Medical University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact LI-Wei Chou, PhD (+886-4-22052121 ext. 2381, chouliwe@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The frequency of nocturnal leg cramps (FC) (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03864770, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2019.