NCT05771441

Brief Summary

In this study, we aimed to determine the effects of heat therapies and neck stabilization exercises on pain, disability, range of motion, and mood of NP patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2020

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2022

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

March 6, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 16, 2023

Completed
Last Updated

March 16, 2023

Status Verified

March 1, 2023

Enrollment Period

2 years

First QC Date

March 6, 2023

Last Update Submit

March 6, 2023

Conditions

Keywords

hot packexerciseultrasound therapy

Outcome Measures

Primary Outcomes (1)

  • change from baseline VAS (visual analog scale) at 6th and 12th week

    The patients were asked to make an assesment of their pain level between 0 and 10 scale

    up to 12 weeks

Secondary Outcomes (4)

  • Change from baseline quality of life (short form 36) at 6th and 12th week

    up to 12 weeks

  • Change from baseline shoulder range of motion (ROM) at 6th and 12th week

    up to 12 weeks

  • Change from baseline Beck depression inventory (BDI) at 6th and 12th week

    up to 12 weeks

  • Change from baseline neck disability index (NDI) at 6th and 12th week

    up to 12 weeks

Study Arms (4)

neck stabilization exercise (NSE)

ACTIVE COMPARATOR

the patients who had NSE

Other: neck stabilization exercise (nse)

NSE + HOT PACK THERAPY

ACTIVE COMPARATOR

the patients who had NSE+ hot pack

Other: NSE + HOT PACK THERAPY

NSE + infrared therapy

ACTIVE COMPARATOR

the patients who had NSE+ infrared therapy

Other: NSE + infrared therapy

NSE + ultrasound therapy

ACTIVE COMPARATOR

the patients who had NSE+ ultrasound therapy

Other: NSE + ultrasound therapy

Interventions

neck stabilization exercise (nse)- exercise

neck stabilization exercise (NSE)

NSE + HOT PACK THERAPY- exercise plus heat therapy

NSE + HOT PACK THERAPY

NSE + infrared therapy- exercise plus heat therapy

NSE + infrared therapy

NSE + ultrasound therapy exercise plus heat therapy

NSE + ultrasound therapy

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Patients with chronic neck pain

You may not qualify if:

  • sensory deficit on neck area, servical disc pathologies, neurological deficit, malignity, secondary causes for neck pain, active inflammation, arthritis on the neck area, serious mental health problems, pregnancy, spine surgery, and having received treatment to the cervical region in the last 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hilal Yeşil

Merkez, Afyonkarahisar, 0300, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Neck PainMotor Activity

Interventions

tau-CrystallinsUltrasonic Therapy

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Intervention Hierarchy (Ancestors)

Phosphopyruvate HydrataseHydro-LyasesCarbon-Oxygen LyasesLyasesEnzymesEnzymes and CoenzymesCrystallinsEye ProteinsProteinsAmino Acids, Peptides, and ProteinsDiathermyHyperthermia, InducedTherapeutics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assoc.Prof.

Study Record Dates

First Submitted

March 6, 2023

First Posted

March 16, 2023

Study Start

May 1, 2020

Primary Completion

May 1, 2022

Study Completion

May 1, 2022

Last Updated

March 16, 2023

Record last verified: 2023-03

Locations