NCT04789811

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 27, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 10, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 25, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 25, 2021

Completed
Last Updated

June 10, 2021

Status Verified

June 1, 2021

Enrollment Period

7 months

First QC Date

February 27, 2021

Last Update Submit

June 9, 2021

Conditions

Nocturnal Leg CrampsMyofascial Pain Syndrome

Keywords

Dry needlingCalf crampMyofascial trigger point

Outcome Measures

Primary Outcomes (5)

  • Change in calf cramp duration

    How many seconds the patient feels cramp is questioned. Higher values represent a worse outcome

    3 months

  • Change in Number of Cramps

    How many times a day the patient feels cramp is recorded. Higher values represent a worse outcome

    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.

    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.

    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.

    3 months

Study Arms (2)

Exercise Group

EXPERIMENTAL

It describes the exercise protocol that the patients will do.

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.

Other: Stretching exerciseOther: Dry needling

Interventions

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.

Exercise GroupExercise plus Dry Needling Group
Dry needlingOTHER

Dry needling: A total of 3 sessions of dry needling, once a week, were applied to the gastrocnemius muscle.

Exercise plus Dry Needling Group

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kars State Hospital

Kars, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Sleep-Wake Transition DisordersMyofascial Pain Syndromes

Interventions

Muscle Stretching ExercisesDry Needling

Condition Hierarchy (Ancestors)

ParasomniasSleep Wake DisordersNervous System DiseasesMental DisordersMuscular DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaComplementary Therapies

Study Officials

  • Fatih Bagcier, M.D.

    Kars State Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Prospective randomised controlled
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 27, 2021

First Posted

March 10, 2021

Study Start

December 1, 2020

Primary Completion

June 25, 2021

Study Completion

June 25, 2021

Last Updated

June 10, 2021

Record last verified: 2021-06

Locations

TU(1)