Chronic Postsurgical PainPhase 2NCT07919457
Phenotype-based Model for Managing Chronic Post-treatment Pain Among Head and Neck Cancer Survivors: a Pilot Study
A Phase 2 study testing Myofascial Pain, Orofacial Bone Pain and Neuralgia Pain in people with Chronic Postsurgical Pain and Chronic Post Cancer Surgery Pain, run by Shaukat Khanum Memorial Cancer Hospital & Research Centre at 1 site in Pakistan.
Trial summary
The goal of this clinical trial is to find out whether a phenotype-based pain management approach can reduce chronic pain in adults (18 years and older) who have completed curative treatment for head and neck cancer and continue to experience chronic post-treatment pain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Postsurgical Pain, Chronic Post Cancer Surgery Pain, Chronic Post Operative Pain
- What is being tested?
- Myofascial Pain, Orofacial Bone Pain and Neuralgia Pain
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 sitePakistan
- Study dates
- 16 Jul 2026to 28 Feb 2027
- Phase
- Phase 2
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults (≥18 years) with history of curative treatment for head and neck cancer
- Chronic post-treatment pain disorder
- Absence of clinical and radiological evidence of recurrent disease
- Ability to provide informed consent
Who cannot join
- Active disease recurrence or metastasis
- Persistent mucositis, oral infection, or hardware failure at the treatment site
- Surgical wound dehiscence
- Cognitive impairment that limits the ability to complete study questionnaires
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
Shaukat Khanum Memorial Cancer Hospital & Research Centre
Lahore, Punjab Province, 54000
Khawaja S Nasir, 924235905000 ext. 4452, shehryarnasir@skm.org.pk
About this study
The goal of this clinical trial is to find out whether a phenotype-based pain management approach can reduce chronic pain in adults (18 years and older) who have completed curative treatment for head and neck cancer and continue to experience chronic post-treatment pain.
The main questions it aims to answer are:
Read more
- Does a phenotype-based pain management approach reduce participants' average pain by at least 75% after one month of treatment?
- Is the treatment safe, with 10% or fewer participants stopping treatment because of side effects?
Participants will:
- Attend three study visits over one month (at baseline, 2 weeks, and 4 weeks).
- Complete questionnaires about their pain, anxiety, depression, medication side effects, and use of pain medicines.
- Undergo a detailed examination to identify the type (phenotype) of their pain.
- Receive a treatment plan tailored to their pain phenotype, which may include medications, trigger point injections, or nerve blocks, depending on their symptoms and pain severity.
- Return for follow-up visits to assess pain relief, medication side effects, and use of breakthrough pain medication.
- Conditions
- Chronic Postsurgical Pain, Chronic Post Cancer Surgery Pain, Chronic Post Operative Pain, Radiation Effects, Chemotherapy Induced Pain
- Being tested
- Myofascial Pain, Orofacial Bone Pain, Neuralgia Pain, Burning Pain, Persistent Pain
- Keywords
- Chronic post-treatment pain, Head and neck cancers, Orofacial Pain, Trigeminal, Radiation therapy, Phenotype
- Medical subject headings
- Pain, Postoperative, Head and Neck Neoplasms, Facial Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Myofascial PainOther
Participants with myofascial pain disorder will initially receive muscle relaxants, such as tizanidine (up to 8 mg per day), cyclobenzaprine (up to 30 mg per day), or amitriptyline (up to 25 mg per day). When the reported pain intensity is 7 or more out of 10, these participants will additionally undergo masticatory or cervical trigger point injections.
Orofacial Bone PainOther
Participants identified with orofacial bone pain disorder who report a pain intensity of less than 7 out of a possible 10 on the Numeric Verbal Rating Scale (NVRS) will receive non-opioid analgesics, including acetaminophen and non-steroidal anti-inflammatory medications. In cases where the pain intensity is 7 or more, participants will be offered targeted nerve blocks. These blocks will be performed along the sensory nerves supplying the affected region to provide localized pain relief.
Neuralgia PainOther
Participants classified with neuralgia will be treated with pregabalin (up to 600 mg per day) or carbamazepine (up to 1200 mg per day). Nerve blocks will be considered for those experiencing pain of 7 or more out of 10. In summary, participants with persistent pain disorder, burning disorder, or neuralgia phenotypes who present with pain intensity scores of 7 or higher will be given nerve blocks around the sensory nerves corresponding to the region of pain.
Burning PainOther
Participants with burning pain will receive pregabalin (up to 600 mg per day), carbamazepine (up to 1200 mg per day), or clonazepam (up to 2 mg per day), and if their pain intensity meets or exceeds 7 out of 10, nerve blocks will similarly be provided to target the sensory pathways involved.
Persistent PainOther
Those diagnosed with persistent pain disorder will be treated with either amitriptyline (up to 25 mg per day) or pregabalin (up to 600 mg per day). Participants in this group who report pain intensity of 7 or more will also be offered nerve blocks administered at sites corresponding to the involved sensory distribution.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | Treatment given based on the clinical phenotype Receives: Other: Myofascial Pain; Other: Orofacial Bone Pain; Other: Neuralgia Pain; Other: Burning Pain; Other: Persistent Pain |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Reduction
A phenotype-based pain management model will provide significant pain relief to participants at one month, defined as at least a 75 percent decrease from average baseline pain
Measured: From enrollment to the end of treatment at 4 weeks
Secondary outcomes (1)
Safety Profile
Discontinuation of assigned phenotype-based therapy due to adverse events by four weeks is 10 percent or less.
Measured: From enrollment to the end of treatment at 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2026
- Study start16 Jul 2026
- Primary completion31 Jan 2027 (estimated)
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Chronic Postsurgical PainStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- All participants will undergo a structured assessment process comprising three visits over a one-month period. In the first visit, history and clinical examination will be conducted, and participants will be assigned clinical phenotypes of HNC-related pain (Myofascial pain disorder, Orofacial bone pain disorder, Burning pain disorder, Neuralgia, Persistent pain disorder). They will receive medications based on their clinical phenotype. The second review will take place 2 weeks after the first visit. The subjects will be asked about the pain (intensity, location, duration, quality, and frequency), medication-related side effects, episodes of breakthrough pain, and use of abortive analgesics. The third assessment will occur after 1 month (4 weeks) of the first visit. Data collected will mirror that of the second visit, including detailed pain assessment, medication side effects, breakthrough pain frequency, and analgesic use.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shaukat Khanum Memorial Cancer Hospital & Research Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07919457
- Sponsor's protocol ID
- IRB-26-02
- Status last verified
- Nov 2026
- First submitted
- 1 Nov 2026
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD will be shared with the journal at the time of publication. To ensure the confidentiality of subject information, each subject enrolled will be assigned a unique serial number.
Publications
Bajwa ZH, Smith SS, Khawaja SN, Scrivani SJ. Cranial Neuralgias. Oral Maxillofac Surg Clin North Am. 2016 Aug;28(3):351-70. doi: 10.1016/j.coms.2016.04.001.
PubMed 27475511Nasir KS, Hafeez H, Jamshed A, Hussain RT. Effectiveness of Nerve Blocks for the Management of Head and Neck Cancer Associated Neuropathic Pain Disorders; a Retrospective Study. J Cancer Allied Spec. 2020 May 12;6(2):e367. doi: 10.37029/jcas.v6i2.367. eCollection 2020.
PubMed 37197605Khawaja SN, Scrivani SJ. Head and Neck Cancer-Related Pain. Dent Clin North Am. 2023 Jan;67(1):129-140. doi: 10.1016/j.cden.2022.07.010. Epub 2022 Oct 27.
PubMed 36404073Hernandez-Nuno de la Rosa MF, Guerrero P, Alturki SA, Scrivani SJ. Masticatory Myofascial Pain Disorders. Dent Clin North Am. 2023 Jan;67(1):1-11. doi: 10.1016/j.cden.2022.07.001. Epub 2022 Oct 27.
PubMed 36404071Khawaja SN, Scrivani SJ. Trigeminal Neuralgia. Dent Clin North Am. 2023 Jan;67(1):99-115. doi: 10.1016/j.cden.2022.07.008. Epub 2022 Oct 27.
PubMed 36404084Khawaja SN, Alaswaiti OF, Scrivani SJ. Burning Mouth Syndrome. Dent Clin North Am. 2023 Jan;67(1):49-60. doi: 10.1016/j.cden.2022.07.004. Epub 2022 Oct 27.
PubMed 36404080Khawaja SN, Rehman SA, Mansoor M, Hafeez H. Chronic Post-Treatment Pain in Head and Neck Cancer Survivors: A Descriptive Analysis of Phenotypic Overlap. Oral Dis. 2026 Mar;32(3):832-839. doi: 10.1111/odi.70129. Epub 2025 Oct 24.
PubMed 41133463
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phenotype-based Model for Managing Chronic Post-treatment Pain Among Head and Neck Cancer Survivors: a Pilot Study
- ClinicalTrials.gov ID
- NCT07919457
- Acronym / sponsor ID
- IRB-26-02
- Conditions
- Chronic Postsurgical Pain, Chronic Post Cancer Surgery Pain, Chronic Post Operative Pain, Radiation Effects, Chemotherapy Induced Pain
- Keywords
- Chronic post-treatment pain, Head and neck cancers, Orofacial Pain, Trigeminal, Radiation therapy, Phenotype
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Shaukat Khanum Memorial Cancer Hospital & Research CentreUniversity, hospital or other
- Study start
- 16 Jul 2026 (actual)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 5 Nov 2026 (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 goal of this clinical trial is to find out whether a phenotype-based pain management approach can reduce chronic pain in adults (18 years and older) who have completed curative treatment for head and neck cancer and continue to experience chronic post-treatment pain.
The main questions it aims to answer are:
- Does a phenotype-based pain management approach reduce participants' average pain by at least 75% after one month of treatment?
- Is the treatment safe, with 10% or fewer participants stopping treatment because of side effects?
Participants will:
- Attend three study visits over one month (at baseline, 2 weeks, and 4 weeks).
- Complete questionnaires about their pain, anxiety, depression, medication side effects, and use of pain medicines.
- Undergo a detailed examination to identify the type (phenotype) of their pain.
- Receive a treatment plan tailored to their pain phenotype, which may include medications, trigger point injections, or nerve blocks, depending on their symptoms and pain severity.
- Return for follow-up visits to assess pain relief, medication side effects, and use of breakthrough pain medication.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants will undergo a structured assessment process comprising three visits over a one-month period. In the first visit, history and clinical examination will be conducted, and participants will be assigned clinical phenotypes of HNC-related pain (Myofascial pain disorder, Orofacial bone pain disorder, Burning pain disorder, Neuralgia, Persistent pain disorder). They will receive medications based on their clinical phenotype. The second review will take place 2 weeks after the first visit. The subjects will be asked about the pain (intensity, location, duration, quality, and frequency), medication-related side effects, episodes of breakthrough pain, and use of abortive analgesics. The third assessment will occur after 1 month (4 weeks) of the first visit. Data collected will mirror that of the second visit, including detailed pain assessment, medication side effects, breakthrough pain frequency, and analgesic use.
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Other: Myofascial Pain, Other: Orofacial Bone Pain, Other: Neuralgia Pain, Other: Burning Pain, Other: Persistent PainTreatment given based on the clinical phenotype |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults (≥18 years) with history of curative treatment for head and neck cancer
- Chronic post-treatment pain disorder
- Absence of clinical and radiological evidence of recurrent disease
- Ability to provide informed consent
Key exclusion criteria (4 listed)
- Active disease recurrence or metastasis
- Persistent mucositis, oral infection, or hardware failure at the treatment site
- Surgical wound dehiscence
- Cognitive impairment that limits the ability to complete study questionnaires
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 |
|---|---|---|
| Myofascial PainParticipants with myofascial pain disorder will initially receive muscle relaxants, such as tizanidine (up to 8 mg per day), cyclobenzaprine (up to 30 mg per day), or amitriptyline (up to 25 mg per day). When the reported pain intensity is 7 or more out of 10, these participants will additionally undergo masticatory or cervical trigger point injections. | Other | Treatment Group |
| Orofacial Bone PainParticipants identified with orofacial bone pain disorder who report a pain intensity of less than 7 out of a possible 10 on the Numeric Verbal Rating Scale (NVRS) will receive non-opioid analgesics, including acetaminophen and non-steroidal anti-inflammatory medications. In cases where the pain intensity is 7 or more, participants will be offered targeted nerve blocks. These blocks will be performed along the sensory nerves supplying the affected region to provide localized pain relief. | Other | Treatment Group |
| Neuralgia PainParticipants classified with neuralgia will be treated with pregabalin (up to 600 mg per day) or carbamazepine (up to 1200 mg per day). Nerve blocks will be considered for those experiencing pain of 7 or more out of 10. In summary, participants with persistent pain disorder, burning disorder, or neuralgia phenotypes who present with pain intensity scores of 7 or higher will be given nerve blocks around the sensory nerves corresponding to the region of pain. | Other | Treatment Group |
| Burning PainParticipants with burning pain will receive pregabalin (up to 600 mg per day), carbamazepine (up to 1200 mg per day), or clonazepam (up to 2 mg per day), and if their pain intensity meets or exceeds 7 out of 10, nerve blocks will similarly be provided to target the sensory pathways involved. | Other | Treatment Group |
| Persistent PainThose diagnosed with persistent pain disorder will be treated with either amitriptyline (up to 25 mg per day) or pregabalin (up to 600 mg per day). Participants in this group who report pain intensity of 7 or more will also be offered nerve blocks administered at sites corresponding to the involved sensory distribution. | Other | Treatment Group |
Primary outcome
Pain Reduction
Time frame: From enrollment to the end of treatment at 4 weeks
A phenotype-based pain management model will provide significant pain relief to participants at one month, defined as at least a 75 percent decrease from average baseline pain
1 secondary outcome
Safety Profile
Time frame: From enrollment to the end of treatment at 4 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 5 Nov 2026.
- Background: PubMed 27475511Bajwa ZH, Smith SS, Khawaja SN, Scrivani SJ. Cranial Neuralgias. Oral Maxillofac Surg Clin North Am. 2016 Aug;28(3):351-70. doi: 10.1016/j.coms.2016.04.001.
- Background: PubMed 37197605Nasir KS, Hafeez H, Jamshed A, Hussain RT. Effectiveness of Nerve Blocks for the Management of Head and Neck Cancer Associated Neuropathic Pain Disorders; a Retrospective Study. J Cancer Allied Spec. 2020 May 12;6(2):e367. doi: 10.37029/jcas.v6i2.367. eCollection 2020.
- Background: PubMed 36404073Khawaja SN, Scrivani SJ. Head and Neck Cancer-Related Pain. Dent Clin North Am. 2023 Jan;67(1):129-140. doi: 10.1016/j.cden.2022.07.010. Epub 2022 Oct 27.
- Background: PubMed 36404071Hernandez-Nuno de la Rosa MF, Guerrero P, Alturki SA, Scrivani SJ. Masticatory Myofascial Pain Disorders. Dent Clin North Am. 2023 Jan;67(1):1-11. doi: 10.1016/j.cden.2022.07.001. Epub 2022 Oct 27.
- Background: PubMed 36404084Khawaja SN, Scrivani SJ. Trigeminal Neuralgia. Dent Clin North Am. 2023 Jan;67(1):99-115. doi: 10.1016/j.cden.2022.07.008. Epub 2022 Oct 27.
- Background: PubMed 36404080Khawaja SN, Alaswaiti OF, Scrivani SJ. Burning Mouth Syndrome. Dent Clin North Am. 2023 Jan;67(1):49-60. doi: 10.1016/j.cden.2022.07.004. Epub 2022 Oct 27.
- Background: PubMed 41133463Khawaja SN, Rehman SA, Mansoor M, Hafeez H. Chronic Post-Treatment Pain in Head and Neck Cancer Survivors: A Descriptive Analysis of Phenotypic Overlap. Oral Dis. 2026 Mar;32(3):832-839. doi: 10.1111/odi.70129. Epub 2025 Oct 24.
- Individual participant dataSharing planned: Yes. IPD will be shared with the journal at the time of publication. To ensure the confidentiality of subject information, each subject enrolled will be assigned a unique serial number.
Related trials for Chronic Postsurgical Pain
RecruitingObservational study
Quality of Life and Pain After Appendectomy in Children
Chronic Pain, Postoperative, Quality of Life
Not yet recruitingPhase 1
Simultaneous Engagement of Networks for Alleviating Pain (SENAP)
Neuropathic Pain, Postherpetic Neuralgia
Recruiting
Radiofrequency Ablation for the Treatment of Post-knee Arthroplasty Chronic Pain.
Chronic Post-surgical Pain, Chronic Post Operative Pain
Not yet recruiting
Opioid Reduction and Enhanced Recovery in Orthopaedic Surgery (OREOS)-Knee
Knee Arthroplasty, Total, Partial Knee Arthroplasty
Recruiting
Combined Popliteal and Adductor Canal Blocks for Postoperative Analgesia in Children With Cerebral Palsy
Cerebral Palsy, Postoperative Pain
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Myofascial Pain, Orofacial Bone Pain and Neuralgia Pain in people with Chronic Postsurgical Pain and Chronic Post Cancer Surgery Pain, run by Shaukat Khanum Memorial Cancer Hospital & Research Centre at 1 site in Pakistan.
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 4 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Khawaja S Nasir (924235905000 ext. 4452, shehryarnasir@skm.org.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Reduction (time frame: From enrollment to the end of treatment at 4 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 NCT07919457, which also lists 7 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 5 Nov 2026; AzTrials last refreshed its copy on 5 Nov 2026.