Neck Disease, Head and Neck CancerNCT06762574
"Effect of Low Level Laser Therapy on Neuropathic Pain After Neck Dissection Surgery''
A study testing Low Level Laser Therapy in people with Neck Disease, Head and Neck Cancer and Neuropathic Pain, run by Cairo University.
Trial 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 . Read more about this study
- Who is it for?
- Ages 30 to 60 years
- Conditions the study is for
- Neck Disease, Head and Neck Cancer, Neuropathic Pain
- What is being tested?
- Low Level Laser Therapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- No sites listed yet
- Study dates
- 6 Jan 2025to 13 Feb 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 30 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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).
Who cannot join
- A wound in the affected area.
- A cervical disk lesion.
- Cervical spine fracture or spondylolisthesis.
- Rheumatoid arthritis.
- Epilepsy or any psychological
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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 .
Read the detailed description
Patients diagnosed with head and neck cancer are treated with surgery, radiation therapy and/or chemotherapy, with the aim of maximizing survival whilst preserving physical form and function .The surgical dissection of the neck is a typical technique for the management of head and neck malignant growths from the squamous cell carcinoma .
Neck dissection (ND) is performed for known metastatic neck disease, prophylactically in cases where there is increased risk for occult metastatic disease or as a staging procedure. Neck dissection (ND) is used to treat known metastatic neck disease, as a preventative measure against occult metastatic disease. A common surgery for treating malignant growths of the head and neck caused by SCC is surgical ND.
There are various approaches to performing the neck dissection surgery. One of these approaches is the radical neck dissection that involves the total excision of lymph nodes from one side of the neck, the muscle that helps turn the head (sternocleidomastoid muscle), a significant vein (internal jugular vein), and a nerve that is essential in the full-range of movement of the arm and shoulder (spinal accessory nerve).In contrast, the modified radical neck dissection preserves one or more of the aforementioned important structures .
Neck morbidity was common and apparent after cancer treatment; this includes limited ROM, impairment of sensations, and neck pain . In an investigation of 25 patients with permanent neck pain following neck dissection, two types of neck pain were described;neuropathic and myofascial pains.
Furthermore, shoulder and neck symptoms were reported in 37% and 33% of 220 participants who had neck dissection surgery , respectively, while myofascial and neuropathic pains were reported in 46% and 32% of the patients, respectively .
A new definition of pain has been formalized and adopted by International Association for the Study of Pain in January 2020, which states that pain is "An unpleasant sensory and emotional experience associated with or resembling that associated with actual or potential tissue damage".
Surgical resection of a tumor is associated with intractable pain of the shoulder, neck, and craniofacial areas. Correct identification of structures such as the cervical plexus and the spinal accessory nerve reduces the manifestation of chronic pain states . Parwis Agha-Mir-Salim et al. showed the essential role played by the cervical plexus in the development of chronic pain with neuropathic characteristics after several types of radical neck dissections. The cervical plexus is essential for sensory innervation of the cervical region and the skin of the shoulder. It is formed by the anterior division of the first four cervical nerves and it is a sensory anatomical substrate for this region .
Damage of the cervical rootlets during neck dissection may lead to neck sensory abnormality (anesthesia, numbness, and/or neuropathic pain), edema and limitation of neck/shoulder movement, decline in speech and eating abilities.
Neuropathic pain is usually managed with a variety of pharmacological and non-pharmacological therapies Among nonpharmacological treatments Transcranial Electrical Stimulation , acupuncture, massage therapy and Transcutaneous .Recent studies have reported the use of laser therapy in patients with peripheral somatosensory neuropathy and neuropathic pain .Specifically, clinical studies on the effects of laser therapy on injured nerve reported an increase in nerve function .
- Being tested
- Low Level Laser Therapy, Placebo Low Level Laser Therapy
- Keywords
- Neck dissection surgery, Neuropathic pain, Rang of motion
- Medical subject headings
- Head and Neck Neoplasms, Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low Level Laser TherapyOther
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.
Placebo Low Level Laser TherapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Study group receive low level laser Therapy and traditional medical treatment | Active comparator | Not described Receives: Other: Low Level Laser Therapy |
| Control group receive placebo Low Level Laser Therapy and traditional medical treatment | Placebo comparator | Not described Receives: Other: Placebo Low Level Laser Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 .
Measured: 6 weeks
Secondary outcomes (2)
Neck pain
*Visual analogue scale :for acute pain measurement. is the most widely used technique for assessing pain intensity , a continuous scale with a vertical or horizontal line of 100 mm, from 0 to10, whose extremes are designated "no pain" and "worst imaginable pain" (0= no pain; 10= most painful imaginable pain). Patients were instructed to indicate how severe the pain was on that line
Measured: 6 weeks
Neck Rang of motion
*Goniometer: is a reliable method to evaluate active Rang of motion clinically.
ROM of the cervical spine is approximately:
80° to 90° of flexion, 70° of extension, 20° to 45° of lateral flexion, Up to 90° of rotation to both sides.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2025
- Study start6 Jan 2025 (estimated)
- Primary completion13 Jan 2025 (estimated)
- Study completion13 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Neck Disease, Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Masking
- None (open label)
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dalia Fathi Ragab Gawish, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06762574
- Sponsor's protocol ID
- Neck dissection surgery
- Status last verified
- Dec 2024
- First submitted
- 23 Dec 2024
- Last updated
- 7 Jan 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
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.
PubMed 31339967de 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.
PubMed 27639607
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Effect of Low Level Laser Therapy on Neuropathic Pain After Neck Dissection Surgery''
- ClinicalTrials.gov ID
- NCT06762574
- Acronym / sponsor ID
- Neck dissection surgery
- Keywords
- Neck dissection surgery, Neuropathic pain, Rang of motion
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 6 Jan 2025 (estimated)
- Primary completion
- 13 Jan 2025 (estimated)
- Study completion
- 13 Feb 2025 (estimated)
- First posted
- 7 Jan 2025 (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 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 .
Detailed description
Patients diagnosed with head and neck cancer are treated with surgery, radiation therapy and/or chemotherapy, with the aim of maximizing survival whilst preserving physical form and function .The surgical dissection of the neck is a typical technique for the management of head and neck malignant growths from the squamous cell carcinoma .
Neck dissection (ND) is performed for known metastatic neck disease, prophylactically in cases where there is increased risk for occult metastatic disease or as a staging procedure. Neck dissection (ND) is used to treat known metastatic neck disease, as a preventative measure against occult metastatic disease. A common surgery for treating malignant growths of the head and neck caused by SCC is surgical ND.
There are various approaches to performing the neck dissection surgery. One of these approaches is the radical neck dissection that involves the total excision of lymph nodes from one side of the neck, the muscle that helps turn the head (sternocleidomastoid muscle), a significant vein (internal jugular vein), and a nerve that is essential in the full-range of movement of the arm and shoulder (spinal accessory nerve).In contrast, the modified radical neck dissection preserves one or more of the aforementioned important structures .
Neck morbidity was common and apparent after cancer treatment; this includes limited ROM, impairment of sensations, and neck pain . In an investigation of 25 patients with permanent neck pain following neck dissection, two types of neck pain were described;neuropathic and myofascial pains.
Furthermore, shoulder and neck symptoms were reported in 37% and 33% of 220 participants who had neck dissection surgery , respectively, while myofascial and neuropathic pains were reported in 46% and 32% of the patients, respectively .
A new definition of pain has been formalized and adopted by International Association for the Study of Pain in January 2020, which states that pain is "An unpleasant sensory and emotional experience associated with or resembling that associated with actual or potential tissue damage".
Surgical resection of a tumor is associated with intractable pain of the shoulder, neck, and craniofacial areas. Correct identification of structures such as the cervical plexus and the spinal accessory nerve reduces the manifestation of chronic pain states . Parwis Agha-Mir-Salim et al. showed the essential role played by the cervical plexus in the development of chronic pain with neuropathic characteristics after several types of radical neck dissections. The cervical plexus is essential for sensory innervation of the cervical region and the skin of the shoulder. It is formed by the anterior division of the first four cervical nerves and it is a sensory anatomical substrate for this region .
Damage of the cervical rootlets during neck dissection may lead to neck sensory abnormality (anesthesia, numbness, and/or neuropathic pain), edema and limitation of neck/shoulder movement, decline in speech and eating abilities.
Neuropathic pain is usually managed with a variety of pharmacological and non-pharmacological therapies Among nonpharmacological treatments Transcranial Electrical Stimulation , acupuncture, massage therapy and Transcutaneous .Recent studies have reported the use of laser therapy in patients with peripheral somatosensory neuropathy and neuropathic pain .Specifically, clinical studies on the effects of laser therapy on injured nerve reported an increase in nerve function .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (5 listed)
- A wound in the affected area.
- A cervical disk lesion.
- Cervical spine fracture or spondylolisthesis.
- Rheumatoid arthritis.
- Epilepsy or any psychological
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 |
|---|---|---|
| Low Level Laser TherapyLow 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. | Other | Study group receive low level laser Therapy and traditional medical treatment |
| Placebo Low Level Laser TherapyPlacebo 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. | Other | Control group receive placebo Low Level Laser Therapy and traditional medical treatment |
Primary outcome
Neck Neuropathic pain
Time frame: 6 weeks
* 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 .
2 secondary outcomes
Neck pain
Time frame: 6 weeks
Neck Rang of motion
Time frame: 6 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2025.
- Background: PubMed 31339967de 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.
- Results publication: PubMed 27639607de 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.
- Individual participant dataSharing planned: Yes
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Low Level Laser Therapy in people with Neck Disease, Head and Neck Cancer and Neuropathic Pain, run by Cairo University.
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 6 inclusion and 5 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: opening soon, as of the sponsor's last update on 7 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dalia Fathi Gawish (01023575298, daliafathi2018@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neck Neuropathic pain (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06762574, which also lists 2 linked publications.
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 7 Jan 2025.