Nocturnal Leg CrampsNCT04789811
Exercise and Dry Needling Treatment Combination in Nocturnal Calf Cramps
A study testing Stretching exercise and Dry needling in people with Nocturnal Leg Cramps and Myofascial Pain Syndrome, run by Kars State Hospital at 1 site in Turkey (Türkiye).
Trial summary
The Investigators aim to evaluate the effectiveness of dry needling treatment in addition to stretching exercises on cramp duration, cramp intensity, cramp frequency, sleep quality, and sensitivity of myofascial trigger points in patients with nocturnal calf cramp. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Nocturnal Leg Cramps, Myofascial Pain Syndrome
- What is being tested?
- Stretching exercise and Dry needling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2020to 25 Jun 2021
- 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 18 to 50 years
- No healthy volunteers
- Adult
Who may be able to join
- Patients with only nocturnal calf cramp
- Patients with a trigger point in the unilateral gastrocnemius muscle
- Being between the ages of 18-50
Who cannot join
- Patients using diuretics or hypertension medications that may trigger cramping
- Those with a chronic disease history
- Those diagnosed with spinal stenosis
- Electrolyte disturbance in laboratory tests
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effectiveness of Exercise and Dry Needling Treatment Combination in Patients With Nocturnal Calf Cramps
The Investigators aim to evaluate the effectiveness of dry needling treatment in addition to stretching exercises on cramp duration, cramp intensity, cramp frequency, sleep quality, and sensitivity of myofascial trigger points in patients with nocturnal calf cramp.
Read the detailed description
Nocturnal leg cramps are sudden, involuntary, painful contractions of the lower extremity in the nighttime, most often in the calf muscles, that gradually lessens. Its etiology is not clear. It can be seen in electrolyte disturbances, drug side effects, neuromuscular diseases, diabetes mellitus, peripheral vascular pathologies. It has been mentioned in the literature that myofascial trigger points in the gastrocnemius muscle may be associated with nocturnal calf cramps. Our aim in this study is to evaluate the effectiveness of the combination of stretching exercises and dry needling therapy on cramp duration, cramp intensity, cramp frequency, sleep quality, and algometer measurement in patients with nocturnal calf cramps and whose had myofascial trigger point in the gastrocnemius muscle.
- Conditions
- Nocturnal Leg Cramps, Myofascial Pain Syndrome
- Being tested
- Stretching exercise, Dry needling
- Keywords
- Dry needling, Calf cramp, Myofascial trigger point
- Medical subject headings
- Sleep-Wake Transition Disorders, Myofascial Pain Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stretching exerciseOther
Stretching exercise: Stretching exercises were planned for 30 seconds, ten repetitions for each stretching, 10 minutes in total, four days a week, for two weeks.
Dry needlingOther
Dry needling: A total of 3 sessions of dry needling, once a week, were applied to the gastrocnemius muscle.
| Study group | Role | What they receive |
|---|---|---|
| Exercise Group | Experimental | It describes the exercise protocol that the patients will do. Receives: Other: Stretching exercise |
| Exercise plus Dry Needling Group | Experimental | It describes the exercise protocol to be performed by the patients and the methodology of dry needling to be applied. Receives: Other: Stretching exercise; Other: Dry needling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in calf cramp duration
How many seconds the patient feels cramp is questioned. Higher values represent a worse outcome
Measured: 3 months
Change in Number of Cramps
How many times a day the patient feels cramp is recorded. Higher values represent a worse outcome
Measured: 3 months
Change in cramp intensity levels with visual analog scale
How intense the cramp felt by the patient was recorded with a visual analog scale. The score is between 0 to 10, and higher values represent a worse outcome.
Measured: 3 months
Change in algometric sensitivity measurement
Myofascial trigger point sensitivity in the gastrocnemius muscle was measured with an algometer. Higher scores represent a worse outcome.
Measured: 3 months
Change in sleep quality
The sleep quality of the patients was evaluated with the Pittsburgh Sleep Quality index. The global PSQI score is then calculated by totaling the seven component scores, providing an overall score ranging from 0 to 21, where lower scores denote a healthier sleep quality.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2021
- Study start1 Dec 2020
- Primary completion25 Jun 2021 (estimated)
- Study completion25 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nocturnal Leg CrampsStudies of the same condition, open and under way.
- 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
- Model description
- Prospective randomised controlled
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kars State Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatih Bagcier, Kars State Hospital
- Investigators
- Fatih Bagcier, M.D., Principal investigator, Kars State Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04789811
- Sponsor's protocol ID
- Biruni University
- Status last verified
- Jun 2021
- First submitted
- 27 Feb 2021
- Last updated
- 10 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Exercise and Dry Needling Treatment Combination in Patients With Nocturnal Calf Cramps
- ClinicalTrials.gov ID
- NCT04789811
- Acronym / sponsor ID
- Biruni University
- Conditions
- Nocturnal Leg Cramps, Myofascial Pain Syndrome
- Keywords
- Dry needling, Calf cramp, Myofascial trigger point
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Kars State HospitalUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 25 Jun 2021 (estimated)
- Study completion
- 25 Jun 2021 (estimated)
- First posted
- 10 Mar 2021 (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.
The Investigators aim to evaluate the effectiveness of dry needling treatment in addition to stretching exercises on cramp duration, cramp intensity, cramp frequency, sleep quality, and sensitivity of myofascial trigger points in patients with nocturnal calf cramp.
Detailed description
Nocturnal leg cramps are sudden, involuntary, painful contractions of the lower extremity in the nighttime, most often in the calf muscles, that gradually lessens. Its etiology is not clear. It can be seen in electrolyte disturbances, drug side effects, neuromuscular diseases, diabetes mellitus, peripheral vascular pathologies. It has been mentioned in the literature that myofascial trigger points in the gastrocnemius muscle may be associated with nocturnal calf cramps. Our aim in this study is to evaluate the effectiveness of the combination of stretching exercises and dry needling therapy on cramp duration, cramp intensity, cramp frequency, sleep quality, and algometer measurement in patients with nocturnal calf cramps and whose had myofascial trigger point in the gastrocnemius muscle.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective randomised controlled
| Arm | Type | Receives |
|---|---|---|
| Exercise Group | Experimental | Other: Stretching exerciseIt describes the exercise protocol that the patients will do. |
| Exercise plus Dry Needling Group | Experimental | Other: Stretching exercise, Other: Dry needlingIt describes the exercise protocol to be performed by the patients and the methodology of dry needling to be applied. |
Who may qualify
- Ages
- 18 to 50 years
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients with only nocturnal calf cramp
- Patients with a trigger point in the unilateral gastrocnemius muscle
- Being between the ages of 18-50
Key exclusion criteria (4 listed)
- Patients using diuretics or hypertension medications that may trigger cramping
- Those with a chronic disease history
- Those diagnosed with spinal stenosis
- Electrolyte disturbance in laboratory tests
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 |
|---|---|---|
| Stretching exerciseStretching exercise: Stretching exercises were planned for 30 seconds, ten repetitions for each stretching, 10 minutes in total, four days a week, for two weeks. | Other | Exercise Group, Exercise plus Dry Needling Group |
| Dry needlingDry needling: A total of 3 sessions of dry needling, once a week, were applied to the gastrocnemius muscle. | Other | Exercise plus Dry Needling Group |
Primary outcome
Change in calf cramp duration
Time frame: 3 months
How many seconds the patient feels cramp is questioned. Higher values represent a worse outcome
Change in Number of Cramps
Time frame: 3 months
How many times a day the patient feels cramp is recorded. Higher values represent a worse outcome
Change in cramp intensity levels with visual analog scale
Time frame: 3 months
How intense the cramp felt by the patient was recorded with a visual analog scale. The score is between 0 to 10, and higher values represent a worse outcome.
Change in algometric sensitivity measurement
Time frame: 3 months
Myofascial trigger point sensitivity in the gastrocnemius muscle was measured with an algometer. Higher scores represent a worse outcome.
Change in sleep quality
Time frame: 3 months
The sleep quality of the patients was evaluated with the Pittsburgh Sleep Quality index. The global PSQI score is then calculated by totaling the seven component scores, providing an overall score ranging from 0 to 21, where lower scores denote a healthier sleep quality.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2021.
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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.
Fatih Bagcier, M.D. principal investigator
Kars State Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stretching exercise and Dry needling in people with Nocturnal Leg Cramps and Myofascial Pain Syndrome, run by Kars State Hospital at 1 site in Turkey (Türkiye).
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 3 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 10 Jun 2021. 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 Turkey (Türkiye). 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in calf cramp duration (time frame: 3 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Jun 2021.