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Exercise and Dry Needling Treatment Combination in Nocturnal Calf Cramps

Primary Purpose

Nocturnal Leg Cramps, Myofascial Pain Syndrome

Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Stretching exercise
Dry needling
Sponsored by
Kars State Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nocturnal Leg Cramps focused on measuring Dry needling, Calf cramp, Myofascial trigger point

Eligibility Criteria

18 Years - 50 Years (Adult)Does not accept healthy volunteers

Inclusion Criteria:

  • Patients with only nocturnal calf cramp
  • Patients with a trigger point in the unilateral gastrocnemius muscle
  • Being between the ages of 18-50

Exclusion Criteria:

  • 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

Sites / Locations

  • Kars State Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Exercise Group

Exercise plus Dry Needling Group

Arm Description

It describes the exercise protocol that the patients will do.

It describes the exercise protocol to be performed by the patients and the methodology of dry needling to be applied.

Outcomes

Primary Outcome Measures

Change in calf cramp duration
How many seconds the patient feels cramp is questioned. Higher values represent a worse outcome
Change in Number of Cramps
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
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
Myofascial trigger point sensitivity in the gastrocnemius muscle was measured with an algometer. Higher scores represent a worse outcome.
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.

Secondary Outcome Measures

Full Information

First Posted
February 27, 2021
Last Updated
June 9, 2021
Sponsor
Kars State Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04789811
Brief Title
Exercise and Dry Needling Treatment Combination in Nocturnal Calf Cramps
Official Title
The Effectiveness of Exercise and Dry Needling Treatment Combination in Patients With Nocturnal Calf Cramps
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Unknown status
Study Start Date
December 1, 2020 (Actual)
Primary Completion Date
June 25, 2021 (Anticipated)
Study Completion Date
June 25, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kars State 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nocturnal Leg Cramps, Myofascial Pain Syndrome
Keywords
Dry needling, Calf cramp, Myofascial trigger point

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective randomised controlled
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Exercise Group
Arm Type
Experimental
Arm Description
It describes the exercise protocol that the patients will do.
Arm Title
Exercise plus Dry Needling Group
Arm Type
Experimental
Arm Description
It describes the exercise protocol to be performed by the patients and the methodology of dry needling to be applied.
Intervention Type
Other
Intervention Name(s)
Stretching exercise
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Dry needling
Intervention Description
Dry needling: A total of 3 sessions of dry needling, once a week, were applied to the gastrocnemius muscle.
Primary Outcome Measure Information:
Title
Change in calf cramp duration
Description
How many seconds the patient feels cramp is questioned. Higher values represent a worse outcome
Time Frame
3 months
Title
Change in Number of Cramps
Description
How many times a day the patient feels cramp is recorded. Higher values represent a worse outcome
Time Frame
3 months
Title
Change in cramp intensity levels with visual analog scale
Description
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.
Time Frame
3 months
Title
Change in algometric sensitivity measurement
Description
Myofascial trigger point sensitivity in the gastrocnemius muscle was measured with an algometer. Higher scores represent a worse outcome.
Time Frame
3 months
Title
Change in sleep quality
Description
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.
Time Frame
3 months

10. Eligibility

Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with only nocturnal calf cramp Patients with a trigger point in the unilateral gastrocnemius muscle Being between the ages of 18-50 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fatih Bagcier, M.D.
Organizational Affiliation
Kars State Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kars State Hospital
City
Kars
Country
Turkey

12. IPD Sharing Statement

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Exercise and Dry Needling Treatment Combination in Nocturnal Calf Cramps

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