"Effect of Low Level Laser Therapy on Neuropathic Pain After Neck Dissection Surgery''

NCT06762574 | Not Yet Recruiting

• 1 other identifier: Neck dissection surgery
• Study Type: interventional
• Target: 52
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of the study was to evaluate the effect of Low Level Laser Therapy on neuropathic pain after neck dissection surgery. It was hypothesized that: Low Level Laser Therapy is effective on improving Neuropathic pain post neck dissection surgery .

Conditions

Neck Disease, Head and Neck Cancer; Neuropathic Pain

Keywords

Neck dissection surgery; Neuropathic pain; Rang of motion

Outcome Measures

Primary Outcomes (1)

• Neck Neuropathic pain

  \* Douleur Neuropathique 4 questionnaire : It is a screening questionnaire to identify neuropathic pain in clinical practice and research, it showed significant accuracy of 83% sensitivity and 90% specificity.It is made up of seven items related to symptoms and three items related to physical evaluation . Each item is scored 1 if the answer is positive and zero if negative, leading to a minimum score of zero and maximum of 10. Cut-off point is four, being that scores equal to or above 4 suggest neuropathic pain .

  6 weeks

Secondary Outcomes (2)

• Neck pain

  6 weeks

• Neck Rang of motion

  6 weeks

Study Arms (2)

Study group receive low level laser Therapy and traditional medical treatment

ACTIVE COMPARATOR

Other: Low Level Laser Therapy

Control group receive placebo Low Level Laser Therapy and traditional medical treatment

PLACEBO COMPARATOR

Other: Placebo Low Level Laser Therapy

Interventions

Low Level Laser Therapy OTHER

Low Level Laser Therapy sometimes known as Low Level Light Therapy or Photobiomodulation (PBM) is a low intensity light therapy. The effect is photochemical not thermal. The light triggers biochemical changes within cells and can be compared to the process of photosynthesis in plants, where the photons are absorbed by cellular photoreceptors and triggers chemical changes.

Study group receive low level laser Therapy and traditional medical treatment

Placebo Low Level Laser Therapy OTHER

Placebo Low Level Laser Therapy:turning on the device with covering probe by aluminum foil and ask patient to wear sun glasses to obtain the placebo effect.

Control group receive placebo Low Level Laser Therapy and traditional medical treatment

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Fiftyـtwo patients of both genders with age ranged between 30 to 60 years will participate in this study.
• All patients had neuropathic pain following Unilateral radical neck dissection surgery.
• All patients had history of neuropathic pain involving superficial cervical plexus after unilateral radical neck dissection surgery.
• All patients had moderate or severe pain of tingling,numbness and electric nature following neck dissection surgery. NP confined to the C2-C4 distributions, involves one or more branches of the SCP;especially in the skin overlying lateral neck .
• Informed consent was obtained from every patient enrolled in the trial.
• Moderate to severe pain (VAS score \>4).

You may not qualify if:

• A wound in the affected area.
• A cervical disk lesion.
• Cervical spine fracture or spondylolisthesis.
• Rheumatoid arthritis.
• Epilepsy or any psychological

Sponsors & Collaborators

• Cairo University: lead

Related Publications (2)

• de Pedro M, Lopez-Pintor RM, de la Hoz-Aizpurua JL, Casanas E, Hernandez G. Efficacy of Low-Level Laser Therapy for the Therapeutic Management of Neuropathic Orofacial Pain: A Systematic Review. J Oral Facial Pain Headache. 2020 Winter;34(1):13-30. doi: 10.11607/ofph.2310. Epub 2019 Jul 24.

  PMID: 31339967 BACKGROUND

• de Andrade AL, Bossini PS, Parizotto NA. Use of low level laser therapy to control neuropathic pain: A systematic review. J Photochem Photobiol B. 2016 Nov;164:36-42. doi: 10.1016/j.jphotobiol.2016.08.025. Epub 2016 Aug 31.

  PMID: 27639607 BACKGROUND

MeSH Terms

Conditions

Head and Neck Neoplasms; Neuralgia

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Central Study Contacts

Dalia Fathi Gawish

CONTACT

01023575298; daliafathi2018@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physical therapist

Study Record Dates

• First Submitted: December 23, 2024
• First Posted: January 7, 2025
• Study Start: January 6, 2025
• Primary Completion: January 13, 2025
• Study Completion: February 13, 2025
• Last Updated: January 7, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share